RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Marquette, MI, US
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) appears in FDA device records in Marquette, MI. FDA records list 100 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 91 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
5 namesFDA records resolved to RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Pioneer Surgical Technology, Inc.registration, 510(k), enforcement report, recall
- Regeneration Technologies, Inc.510(k), recall
- Rti Biologics, Inc.510(k), recall
- Rti Surgical, Inc.510(k), enforcement report, recall
- RTI Surgical, Inc. (dba RTI Biologics, Inc.)registration, 510(k)
510(k) clearance history
Showing 50 of 100FDA records hold 100 510(k) clearances for RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) between 1993 and 2026. The busiest year on record is 2008, with 10. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 6 |
| 1996 | 1 |
| 1997 | 3 |
| 1998 | 1 |
| 1999 | 5 |
| 2000 | 3 |
| 2001 | 1 |
| 2002 | 1 |
| 2004 | 2 |
| 2005 | 8 |
| 2006 | 3 |
| 2007 | 5 |
| 2008 | 10 |
| 2009 | 5 |
| 2010 | 7 |
| 2011 | 8 |
| 2012 | 6 |
| 2013 | 5 |
| 2014 | 7 |
| 2015 | 1 |
| 2017 | 3 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261271 | Cable-Ready® Cable Grip System | JDQ | Substantially Equivalent | |
| K253145 | Pre-Sutured Tendon | GAT | Substantially Equivalent | |
| K251436 | Resolve Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | MQV | Substantially Equivalent | |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | GAT | Substantially Equivalent | |
| K222493 | CODA™ Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K211408 | CervAlign® Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K192396 | Streamline MIS Spinal Fixation System | NKB | Substantially Equivalent | |
| K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | MAX | Substantially Equivalent | |
| K163673 | Fortilink™-C with TETRAfuse™ 3D Technology | ODP | Substantially Equivalent | |
| K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | MAX | Substantially Equivalent | |
| K150521 | Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System | ODP | Substantially Equivalent | |
| K142070 | FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS | FTM | Substantially Equivalent | |
| K140696 | STREAMLINE TL SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K132850 | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM | GXQ | Substantially Equivalent | |
| K133455 | CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC | MAX | Substantially Equivalent | |
| K133623 | C-PLUS | ODP | Substantially Equivalent | |
| K132050 | NB3D BONE VOID FILLER | MQV | Substantially Equivalent | |
| K133785 | TRITIUM STERNAL CABLE PLATE SYSTEM | JDQ | Substantially Equivalent | |
| K131724 | PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE | MQP | Substantially Equivalent | |
| K131100 | STREAMLINE TL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K130427 | PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K130286 | STREAMLINE MIS SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K123356 | FORTIVA PORCINE DERMIS | FTM | Substantially Equivalent | |
| K121725 | PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM | KWP | Substantially Equivalent | |
| K122293 | PIONEER STERNAL CABLE PLATE SYSTEM | HRS | Substantially Equivalent | |
| K120016 | PIONEER STERNAL ASSIST IMPLANT SYSTEM | HRS | Substantially Equivalent | |
| K120724 | PIONEER LATERAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K112757 | PIONEER POSTERIOR CERVICO THORACIC SYSTEM | KWP | Substantially Equivalent | |
| K113218 | PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM | NQW | Substantially Equivalent | |
| K111944 | NB3D BONE VOID FILLER | MQV | Substantially Equivalent | |
| K112496 | PIONEER CROSSFUSE II IBF/VBR SYSTEM | MAX | Substantially Equivalent | |
| K111528 | PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES | KWQ | Substantially Equivalent | |
| K111502 | STREAMLINE TL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K110692 | STREAMLINE TL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K110561 | FORTROSS BONE VOID FILLER | MQV | Substantially Equivalent | |
| K110367 | PIONEER SPINAL PROCESS FUSION PLATE | KWP | Substantially Equivalent | |
| K101790 | QUANTUM SPINAL SYSTEM, QUANTUM MIS | NKB | Substantially Equivalent | |
| K101525 | PIONEER SPINOUS PROCESS FUSION PLATE | KWP | Substantially Equivalent | |
| K102903 | PIONEER CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | |
| K093692 | QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES | NKB | Substantially Equivalent | |
| K093771 | QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM | MNH | Substantially Equivalent | |
| K100708 | PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES | KWQ | Substantially Equivalent | |
| K100361 | NANOSS BONE VOID FILLER | MQV | Substantially Equivalent | |
| K092295 | PIONEER POSTERIOR CERVICO-THORACIC SYSTEM | KWP | Substantially Equivalent | |
| K091031 | PIONEER SURGICAL NANOSS BVF-E | MQV | Substantially Equivalent | |
| K091142 | TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 | FTM | Substantially Equivalent | |
| K083449 | E-MATRIX GRAFT BONE EXTENDER | MQV | Substantially Equivalent | |
| K090222 | PIONEER LUMBAR PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K083663 | PACP | KWQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1833824 | 1000115331 | Pioneer Surgical Technology, Inc. | 375 RIVER PARK CIRCLE, Marquette, MI 49855 US | 2026 | and 34 more, listed in full below |
| 3002719998 | 3002719998 | RTI Surgical, Inc. (dba RTI Biologics, Inc.) | 11621 Research Circle, ALACHUA, FL 32615 US | 2026 | and 23 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYQAccessories, Fixation, Spinal Intervertebral Body
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HXNApplier, Cerclage
- HWJAwl
- HXWBender
- HTWBit, Drill
- GFGBit, Surgical
- HXYBrace, Drill
- KTZCaliper
- JDQCerclage, Fixation
- FZOChisel, Surgical, Manual
- HXDClamp
- HXQCrimper, Pin
- FZTCutter, Surgical
- HXZCutter, Wire
- HWRDriver, Prosthesis
- GXQDura Substitute
- GXZElectrode, Needle
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- HWAImpactor
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- HXLMallet
- FTMMesh, Surgical
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- GFIOsteotome, Manual
- HWQPasser
- HXIPasser, Wire, Orthopedic
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- HRSPlate, Fixation, Bone
- HTCPliers, Surgical
- HTRRasp
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- GAFSpatula, Surgical, General & Plastic Surgery
- MQPSpinal Vertebral Body Replacement Device
- JDRStaple, Fixation, Bone
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- EIDSyringe, Restorative And Impression Material
- HXGTamp
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
- HXCWrench
Recall records
Showing 25 of 91| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1244-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1243-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1242-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1241-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1240-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1239-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1238-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1237-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1236-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1235-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1234-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1233-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1232-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1231-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1230-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1229-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1228-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1227-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1226-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1225-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1224-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1223-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1222-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1221-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified | |
| Z-1220-2021 | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion). | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain