Alphatec Spine, Inc.
Carlsbad, CA, US
ALPHATEC SPINE, INC. appears in FDA device records in Carlsbad, CA. FDA records list 121 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 58 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Alphatec Spine, 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.
- Alphatec Mfg., Inc.510(k), recall
510(k) clearance history
Showing 50 of 121FDA records hold 121 510(k) clearances for Alphatec Spine, Inc. between 1990 and 2026. The busiest year on record is 2023, with 11. The most recent is 2026, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 5 |
| 1993 | 1 |
| 1994 | 3 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 5 |
| 2008 | 3 |
| 2009 | 6 |
| 2010 | 4 |
| 2011 | 4 |
| 2012 | 2 |
| 2013 | 4 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 4 |
| 2017 | 1 |
| 2018 | 7 |
| 2019 | 6 |
| 2020 | 7 |
| 2021 | 6 |
| 2022 | 8 |
| 2023 | 11 |
| 2024 | 7 |
| 2025 | 5 |
| 2026 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | NKB | Substantially Equivalent | |
| K253216 | IntraOp Alignment System; CONTOUR3D Bending System | SIN | Substantially Equivalent | |
| K253615 | Invictus Bands System | OWI | Substantially Equivalent | |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | OLO | Substantially Equivalent | |
| K252842 | SafeOp 3: Neural Informatix System | GWF | Substantially Equivalent | |
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | OVD | Substantially Equivalent | |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | KWQ | Substantially Equivalent | |
| K251080 | IdentiTi II Cervical Interbody System | ODP | Substantially Equivalent | |
| K243461 | Calibrate Interbody Systems | Substantially Equivalent | ||
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer | MAX | Substantially Equivalent | |
| K242364 | IdentiTi™ II Interbody System | MAX | Substantially Equivalent | |
| K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | MAX | Substantially Equivalent | |
| K241519 | Invictus® Small Stature Spinal Fixation System | NKB | Substantially Equivalent | |
| K240951 | Invictus Robotic Navigation Instruments | OLO | Substantially Equivalent | |
| K240199 | IntraOp Alignment System | OWB | Substantially Equivalent | |
| K234092 | SafeOp 3: Neural Informatix Systeem | GWF | Substantially Equivalent | |
| K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System | KWQ | Substantially Equivalent | |
| K232345 | ATEC Posterior Navigated Disc Prep Instruments | OLO | Substantially Equivalent | |
| K232504 | Calibrate CCX Interbody System | MAX | Substantially Equivalent | |
| K232173 | Ascend VBR System, Ascend NanoTec VBR System | MQP | Substantially Equivalent | |
| K232044 | Invictus Robotic Navigation Instruments | OLO | Substantially Equivalent | |
| K232275 | Invictus® Spinal Fixation System | NKB | Substantially Equivalent | |
| K232097 | IdentiTi ALIF Interbody Systems | OVD | Substantially Equivalent | |
| K232413 | Fusion Robotic Navigation System | OLO | Substantially Equivalent | |
| K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | MAX | Substantially Equivalent | |
| K230721 | ATEC Lateral Plate System | KWQ | Substantially Equivalent | |
| K223611 | Calibrate LTX Interbody System | MAX | Substantially Equivalent | |
| K223765 | ATEC Lateral Navigation Instruments | OLO | Substantially Equivalent | |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | PML | Substantially Equivalent | |
| K222455 | Calibrate LTX Interbody System | MAX | Substantially Equivalent | |
| K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem | ODP | Substantially Equivalent | |
| K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System | MAX | Substantially Equivalent | |
| K221821 | ATEC IOM Accessory Instruments | PDQ | Substantially Equivalent | |
| K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System | MAX | Substantially Equivalent | |
| K214006 | Invictus® Spinal Fixation System | NKB | Substantially Equivalent | |
| K213849 | SafeOp 2: Neural Informatix System | GWF | Substantially Equivalent | |
| K213443 | Insignia™ Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K213460 | Invictus Spinal Fixation System | NKB | Substantially Equivalent | |
| K211987 | ATEC Alignment App | LLZ | Substantially Equivalent | |
| K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System | MAX | Substantially Equivalent | |
| K211873 | PSX Interbody System | MAX | Substantially Equivalent | |
| K203742 | IdentiTi ALIF Standalone Interbody System | OVD | Substantially Equivalent | |
| K203125 | Invictus™ OCT Spinal Fixation System | NKG | Substantially Equivalent | |
| K202812 | IdentiTi Cervical Standalone Interbody System | OVE | Substantially Equivalent | |
| K203056 | Invictus™ Spinal Fixation System | NKB | Substantially Equivalent | |
| K202587 | ATEC Lateral Interbody System | MAX | Substantially Equivalent | |
| K202327 | Invictus™ OsseoScrew® System | NKB | Substantially Equivalent | |
| K200936 | Invictus™ CT Spinal Fixation System | NKG | Substantially Equivalent | |
| K200995 | Insignia™ Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K192938 | Invictus™ Spinal Fixation System | NKB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2027467 | 2027467 | ALPHATEC SPINE, INC. | 1950 Camino Vida Roble, Carlsbad, CA 92008 US | 2026 | and 65 more, listed in full below |
| 3015537048 | 3015537048 | ALPHATEC SPINE, INC. | 168 Centennial Parkway, Louisville, CO 80027 US | 2026 | |
| 3019878714 | 3019878714 | Alphatec Spine, Inc. | 4101 Willow Lake Blvd., Memphis, TN 38118 US | 2026 | and 65 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- HTWBit, Drill
- HTQBroach
- IKDCable, Electrode
- KTZCaliper
- JOLCatheter And Tip, Suction
- FZOChisel, Surgical, Manual
- JECComponent, Traction, Invasive
- HTFCurette
- GDIDissector, Surgical, General & Plastic Surgery
- HWRDriver, Prosthesis
- GXYElectrode, Cutaneous
- GXZElectrode, Needle
- IKNElectromyograph, Diagnostic
- HTEElevator
- HTDForceps
- HYAForceps, Wire Holding
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- GDZHandle, Scalpel
- HWAImpactor
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HTSKnife, Orthopedic
- FTALight, Surgical, Accessories
- HXLMallet
- GAANeedle, Aspiration And Injection, Disposable
- GFIOsteotome, Manual
- JDWPin, Fixation, Threaded
- HRSPlate, Fixation, Bone
- HXBProbe
- HTRRasp
- HTOReamer
- GADRetractor
- FDGRetractor, Fiberoptic
- HSBRod, Fixation, Intramedullary And Accessories
- HTXRongeur
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- HWDStarter, Bone Screw
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- GWFStimulator, Electrical, Evoked Response
- ETNStimulator, Nerve
- CCXSupport, Patient Position
- LLZSystem, Image Processing, Radiological
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- FQOTable, Operating-Room, Ac-Powered
- FWWTable, Operating-Room, Pneumatic
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
- HWKTrephine
- HXCWrench
Recall records
Showing 25 of 58| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2793-2026 | SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System | Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change. | Class II | Open, Classified | |
| Z-1343-2026 | ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker. | Due a design issue where the navigated array connection geometry is incorrect. | Class II | Open, Classified | |
| Z-1342-2026 | ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker. | Due a design issue where the navigated array connection geometry is incorrect. | Class II | Open, Classified | |
| Z-1065-2025 | Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonsterile; (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, Part #325-07103005, nonsterile; (5) Calibrate CCX-O, 7 x 10 x 30mm 10 degrees, Part #325-07103010, nonsterile; (6) Calibrate CCX-O, 7 x 10 x 30mm 15 degrees, Part #325-07103015, nonsterile; (7) Calibrate CCX-O, 7 x 10 x 35mm 10 degrees, Part #325-07103510, nonsterile; (8) Calibrate CCX-O, 7 x 10 x 35mm 15 degrees, Part #325-07103515, nonsterile; (9) Calibrate CCX-O, 9 x 10 x 25mm 5 degrees, Part #325-09102505, nonsterile; (10) Calibrate CCX-O, 9 x 10 x 25mm 10 degrees, Part #325-09102510, nonsterile; (11) Calibrate CCX-O, 9 x 10 x 30mm 5 degrees, Part #325-09103005, nonsterile; (12) Calibrate CCX-O, 9 x 10 x 30mm 10 degrees, Part #325-09103010, nonsterile; (13) Calibrate CCX-O, 11 x 10 x 30mm 10 degrees, Part #325-11103010, nonsterile; (14) Calibrate CCX-S, 7 x 10 x 22mm 5 degrees, Part #326-07102205, nonsterile; (15) Calibrate CCX-S, 7 x 10 x 22mm 10 degrees, Part #326-07102210, nonsterile; (16) Calibrate CCX-S, 7 x 10 x 22mm 15 degrees, Part #326-07102215, nonsterile; (17) Calibrate CCX-S, 7 x 10 x 26mm 5 degrees, Part #326-07102605, nonsterile; (18) Calibrate CCX-S, 7 x 10 x 26mm 10 degrees, Part #326-07102610, nonsterile; (19) Calibrate CCX-S, 7 x 10 x 26mm 15 degrees, Part #326-07102615, nonsterile; (20) Calibrate CCX-S, 7 x 10 x 30mm 10 degrees, Part #326-07103010, nonsterile; (21) Calibrate CCX-S, 9 x 10 x 22mm 5 degrees, Part #326-09102205, nonsterile; (22) Calibrate CCX-S, 9 x 10 x 22mm 10 degrees, Part #326-09102210, nonsterile; (23) Calibrate CCX-S, 9 x 10 x 26mm 5 degrees, Part #326-09102605, nonsterile; (24) Calibrate CCX-S, 9 x 10 x 26mm 10 degrees, Part #326-09102610, nonsterile; and (25) Calibrate CCX-S, 11 x 10 x 26mm 10 degrees, Part #326-11102610, nonsterile. Convenience kits containing affected implants: (1) Calibrate CCX Oblique Implants, REF CLCCXOIMPA, containing 24 implants/kit, nonsterile; and (2) Calibrate CCX Straight Implants, REF CLCCXSIMPA, containing 36 implants/kit, nonsterile. | Complaints have been received regarding post-operative implant collapse. | Class II | Open, Classified | |
| Z-1182-2024 | IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm 132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm 132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm 232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm 232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm 232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm The IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (ALIF) procedures. | Due to reports of intraoperative graft bolt implantation breakages. | Class II | Open, Classified | |
| Z-2475-2023 | LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF, | Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery. | Class II | Open, Classified | |
| Z-0196-2023 | Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15 TC11050 00840180510810 CI-11050-09102515 Longer IdentiTi PO Trial Tip, 12A X 9P X 10 X 25mm, 15 TC11050 00840180510827 CI-11050-10102515 Longer IdentiTi PO Trial Tip, 13A X 10P X 10 X 25mm, 15 TC11050 00840180510834 CI-11050-11102515 Longer IdentiTi PO Trial Tip, 14A X 11P X 10 X 25mm, 15 TC11050 00840180510841 CI-11050-12102515 Longer IdentiTi PO Trial Tip, 15A X 12P X 10 X 25mm, 15 TC11050 00840180510858 CI-11051-10-07 Longer Rotating Disc Shaver, Parallel, 7mm TC11051 00840180511084 CI-11051-20-13 Longer Rotating Disc Shaver, Parallel, 13mm TC11051 00840180511145 CI-11051-20-15 Longer Rotating Disc Shaver, Parallel, 15mm TC11051 00840180511169 CI-11051-20-09 Longer Rotating Disc Shaver, Parallel, 9mm TC11051 00840180511107 CI-11051-20-08 Longer Rotating Disc Shaver, Parallel, 8mm TC11051 00840180511091 CI-11051-20-11 Longer Rotating Disc Shaver, Parallel, 11mm TC11051 00840180511121 CI-11051-10-06 Longer Rotating Disc Shaver, Parallel, 6mm TC11051 00840180511077 CI-11051-20-10 Longer Rotating Disc Shaver, Parallel, 10mm TC11051 00840180511114 CI-11051-20-14 Longer Rotating Disc Shaver, Parallel, 14mm TC11051 00840180511152 CI-11051-10-05 Longer Rotating Disc Shaver, Parallel, 5mm TC11051 00840180511060 CI-11051-20-12 Longer Rotating Disc Shaver, Parallel, 12mm TC11051 00840180511138 CI-11052-01-022-05 Longer Straight Curette, Size 2 TC11052 00840180511282 CI-11052-02-022-05 Longer Up-Angled Pull Curette, Size 2 TC11052 00840180511299 CI-11052-04-022-05 Longer Right-Angled Pull Curette, Size 2 TC11052 00840180511305 CI-11052-05-022-05 Longer Left-Angled Curette, Size 2 TC11052 00840180511312 CI-11071-021-05 Longer Straight Teardrop Curette, Size 2 TC11071 00840180511275 | Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing. | Class II | Open, Classified | |
| Z-1827-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1826-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1825-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1824-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1823-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1822-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1821-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1820-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1819-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1818-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1817-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1816-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1815-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1814-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1813-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1812-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1811-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated | |
| Z-1810-2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain