Medtronic Sofamor Danek USA Inc
Memphis, TN, US
MEDTRONIC SOFAMOR DANEK USA, INC. appears in FDA device records in Memphis, TN. FDA records list 182 510(k) clearances between and , 191 PMA records and 2 registered establishments. As of , FDA records show 172 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 182FDA records hold 182 510(k) clearances for Medtronic Sofamor Danek USA Inc between 2000 and 2026. The busiest year on record is 2015, with 19. The most recent is 2026, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2001 | 5 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 6 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 4 |
| 2009 | 5 |
| 2010 | 4 |
| 2011 | 11 |
| 2012 | 7 |
| 2013 | 18 |
| 2014 | 16 |
| 2015 | 19 |
| 2016 | 10 |
| 2017 | 9 |
| 2018 | 9 |
| 2019 | 12 |
| 2020 | 6 |
| 2021 | 7 |
| 2022 | 6 |
| 2023 | 4 |
| 2024 | 4 |
| 2025 | 5 |
| 2026 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253011 | Catalyft PL Expandable Interbody System | MAX | Substantially Equivalent | |
| K261020 | Symmetrix™ L Spinal System | MAX | Substantially Equivalent | |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | GEI | Substantially Equivalent | |
| K260216 | CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System | NKB | Substantially Equivalent | |
| K254165 | Infinity™ OCT System | NKG | Substantially Equivalent | |
| K253941 | CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) | NKB | Substantially Equivalent | |
| K253335 | CD Horizon™ Spinal System | NKB | Substantially Equivalent | |
| K253129 | Infinity™ OCT System | NKG | Substantially Equivalent | |
| K251444 | Endoskeleton™ Interbody Systems | MAX | Substantially Equivalent | |
| K251395 | The Rialto™ SI Fusion System | OUR | Substantially Equivalent | |
| K250669 | Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology | MAX | Substantially Equivalent | |
| K241992 | Catalyft™ LS Expandable Interbody System | OVD | Substantially Equivalent | |
| K243007 | CD Horizon™ Spinal System | NKB | Substantially Equivalent | |
| K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | NKB | Substantially Equivalent | |
| K233830 | OsteoCool™ 2.0 RF Ablation System | GEI | Substantially Equivalent | |
| K232141 | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) | NKB | Substantially Equivalent | |
| K231090 | Zevo Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K231184 | CD Horizon™ Spinal System | OLO | Substantially Equivalent | |
| K223764 | INFINITY OCT System | NKG | Substantially Equivalent | |
| K223153 | Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | |
| K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K222383 | Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition | OLO | Substantially Equivalent | |
| K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments | OLO | Substantially Equivalent | |
| K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | |
| K214011 | Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers | OLO | Substantially Equivalent | |
| K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | |
| K212653 | Catalyft LS Expandable Interbody System | MAX | Substantially Equivalent | |
| K211958 | CD Horizon Spinal System | NKB | Substantially Equivalent | |
| K211441 | Navigated Anterolateral Disc Prep Instruments | OLO | Substantially Equivalent | |
| K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System | MAX | Substantially Equivalent | |
| K210425 | Catalyft PL Expandable Interbody System | MAX | Substantially Equivalent | |
| K203678 | CD HORIZON™ Spinal System | NQP | Substantially Equivalent | |
| K203291 | CD Horizon Spinal System Instruments | OLO | Substantially Equivalent | |
| K201407 | CD Horizon™ Spinal System | NKB | Substantially Equivalent | |
| K202328 | CD Horizon Spinal System | NKB | Substantially Equivalent | |
| K191788 | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | MAX | Substantially Equivalent | |
| K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus | MAX | Substantially Equivalent | |
| K193011 | CD Horizon™ Fenestrated Screw Set | NKB | Substantially Equivalent | |
| K192336 | Navigated Anterolateral Disc Prep Instruments | OLO | Substantially Equivalent | |
| K190840 | Medtronic Transportation / Sterilization Cassettes | KCT | Substantially Equivalent | |
| K191066 | CD Horizon™ Astute™ Spinal System | NQP | Substantially Equivalent | |
| K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set | PML | Substantially Equivalent | |
| K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | OLO | Substantially Equivalent | |
| K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | MAX | Substantially Equivalent | |
| K190165 | Capstone Control™ Spinal System | MAX | Substantially Equivalent | |
| K183197 | PYRAMESH™ Implant System | MQP | Substantially Equivalent | |
| K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K183510 | T2 STRATOSPHERE Expandable Corpectomy System | MQP | Substantially Equivalent | |
| K182497 | OsteoCool RF Ablation System | GEI | Substantially Equivalent | |
| K182928 | CD Horizon™ Spinal System | NQP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1030489 | 1000477302 | MEDTRONIC SOFAMOR DANEK USA, INC. | 1800 PYRAMID PLACE, Memphis, TN 38132 US | 2026 | and 108 more, listed in full below |
| 3003120897 | 3003120897 | MEDTRONIC SOFAMOR DANEK USA, INC. | 4340 Swinnea Road, Memphis, TN 38118 US | 2026 | and 112 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HRXArthroscope
- HWJAwl
- HTWBit, Drill
- HTQBroach
- EQJBur, Ear, Nose And Throat
- GEACannula, Surgical, General & Plastic Surgery
- FZOChisel, Surgical, Manual
- FMHContainer, Specimen, Sterile
- HWICorkscrew
- HTFCurette
- FZSCurette, Surgical, General Use
- FZTCutter, Surgical
- HNWDilator, Lachrymal
- GDIDissector, Surgical, General & Plastic Surgery
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- HWRDriver, Prosthesis
- GXZElectrode, Needle
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HTEElevator
- HWBExtractor
- HTDForceps
- HTJGauge, Depth
- GXDGenerator, Lesion, Radiofrequency
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- GDGHook, Surgical, General & Plastic Surgery
- HWAImpactor
- DZEImplant, Endosseous, Root-Form
- DXYImplantable Pacemaker Pulse-Generator
- DXTInjector And Syringe, Angiographic
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HTSKnife, Orthopedic
- FSZLight, Surgical, Carrier
- EZXMesh, Surgical, Metal
- HBBMotor, Drill, Pneumatic
- GEYMotor, Surgical Instrument, Ac-Powered
- GETMotor, Surgical Instrument, Pneumatic Powered
- HAWNeurological Stereotaxic Instrument
- HWMOsteotome
- HRSPlate, Fixation, Bone
- HTCPliers, Surgical
- HXBProbe
- GXIProbe, Radiofrequency Lesion
- HTRRasp
- HTOReamer
- GADRetractor
- HTXRongeur
- HRRScissors, Orthopedic, Surgical
- GWFStimulator, Electrical, Evoked Response
- EZWStimulator, Electrical, Implantable, For Incontinence
- ETNStimulator, Nerve
- FMFSyringe, Piston
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- FSMTray, Surgical, Instrument
- HWKTrephine
Recall records
Showing 25 of 172| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0580-2026 | Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068116. 7. SPACER 6069073 CATALYFT PL40 SHORT 7MM, Model Number: 6069073. 8. SPACER 6069076 CATALYFT PL40 LONG 7MM, Model Number: 6069076. 9. SPACER 6069093 CATALYFT PL40 SHORT 9MM, Model Number: 6069093. 10. SPACER 6069096 CATALYFT PL40 LONG 9MM, Model Number: 6069096. 11. SPACER 6069113 CATALYFT PL40 SHORT 11MM, Model Number: 6069113. 12. SPACER 6069116 CATALYFT PL40 LONG 11MM, Model Number: 6069116. 13. CATALYFT PL IMPLANT SET, Model Number: SPS03143. 14. CATALYFT PL 40 IMPLANT SET, Model Number: SPS03144. 15. KIT CATALYFT PL IMPLANTS, Model Number: SPS04012. 16. KIT CATALYFT PL 40 IMPLANTS, Model Number: SPS04013. 17. CATALYFT PL 40 IMP KIT, Model Number: SPSJEP40. 18. CATALYFT PL 40 HIGH IMP KIT, Model Number: SPSJEP4H. 19. CATALYFT PL 40 SHORT IMP KIT, Model Number: SPSJEP4S. 20. CATALYFT PL 40 SHORT HIGH IMP KIT, Model Number: SPSJEP4T. 21. CATALYFT PL STRAIGHT HIGH IMP KIT, Model Number: SPSJEPSH. 22. CATALYFT PL STRAIGHT IMP KIT, Model Number: SPSJEPSI. These systems utilize the following affected Instructions for Use (IFU), Document M333023W048E, and Surgical Technique Guide, Document M333023W217. | Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur. | Class II | Open, Classified | |
| Z-0167-2024 | Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch. | Class II | Open, Classified | |
| Z-0166-2024 | Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch. | Class II | Open, Classified | |
| Z-0165-2024 | Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch. | Class II | Open, Classified | |
| Z-0164-2024 | Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch. | Class II | Open, Classified | |
| Z-0163-2024 | Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch. | Class II | Open, Classified | |
| Z-0162-2024 | Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch. | Class II | Open, Classified | |
| Z-0161-2024 | Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch. | Class II | Open, Classified | |
| Z-2524-2023 | Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile. | The incorrect product labeling was applied to the product indicating the wrong size of product. | Class II | Open, Classified | |
| Z-2363-2023 | CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K | Incorrect Laser Marking - Solera Awl Tip Tap | Class II | Open, Classified | |
| Z-2123-2023 | Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. | Class II | Open, Classified | |
| Z-2122-2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. | Class II | Open, Classified | |
| Z-2121-2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. | Class II | Open, Classified | |
| Z-2120-2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. | Class II | Open, Classified | |
| Z-2119-2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. | Class II | Open, Classified | |
| Z-2118-2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. | Class II | Open, Classified | |
| Z-2117-2023 | Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. | Class II | Open, Classified | |
| Z-1413-2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3. | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws | Class II | Open, Classified | |
| Z-1412-2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3. | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws | Class II | Open, Classified | |
| Z-1411-2023 | INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3. | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws | Class II | Open, Classified | |
| Z-1410-2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3. | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws | Class II | Open, Classified | |
| Z-1409-2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3. | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws | Class II | Open, Classified | |
| Z-1334-2023 | Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309; f) DBM T600612 XPANSE LARGE-L, REF T600612; Demineralized Bone Matrix (DBM) product | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-1333-2023 | Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT; e) DBM T41120 1CC GRAFTON GEL, REF T41120; f) DBM T41120INT 1CC GRAFTON GEL, REF T41120INT; g) DBM T41130 5CC GRAFTON GEL, REF T41130; h) DBM T41130INT 5CC GRAFTON GEL, REF T41130INT; i) DBM T41150 10CC GRAFTON GEL, REF T41150; j) DBM T41150INT 10CC GRAFTON GEL, REF T41150INT; Demineralized Bone Matrix (DBM) product | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-1332-2023 | Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Demineralized Bone Matrix (DBM) product | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain