Data / Medical devices / United States / Medtronic Sofamor Danek Usa, Inc.
Medtronic Sofamor Danek Usa, Inc.: FDA-registered device maker in Memphis, TN, United States, 455 510(k) clearances and 9 PMA approvals
Medtronic Sofamor Danek Usa, Inc. is registered with the FDA (registration 1030489) in Memphis, TN, United States. It lists 118 device types. The FDA files 455 510(k) clearances and 9 PMA approvals under its listings, the newest dated July 17, 2026. 43 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1030489
- FEI number
- 1000477302
- Address
- 1800 Pyramid Place, Memphis, TN, United States, 38132
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- February 15, 1978
- Registered through
- 2026
- Brand names listed
- , MOTORS, ACPii Atlantis Cervial Plate, AFFINITY, ANTERIOR CERVICAL PLATE SYSTEM, ARCHITEX, ARTHROSCOPE, ARTiC-L 3D Ti Spinal System with TiONIC Technology, ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS" Anterior Cervical Plate System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 455.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 17, 2026 | K253011 | Catalyft PL Expandable Interbody System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 14, 2026 | K261020 | Symmetrix L Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 21, 2026 | K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 21, 2026 | K254165 | Infinity OCT System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 7, 2026 | K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 24, 2025 | K253335 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 24, 2025 | K253129 | Infinity OCT System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 28, 2024 | K241992 | Catalyft LS Expandable Interbody System | OVD | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 23, 2024 | K243007 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| March 27, 2024 | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 28, 2024 | K233830 | OsteoCool 2.0 RF Ablation System | GEI | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 16, 2023 | K232141 | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 18, 2023 | K230716 | Robotic Graft Delivery Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| May 26, 2023 | K231184 | CD Horizon Spinal System | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 23, 2023 | K223494 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| September 29, 2022 | K222383 | Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 25, 2022 | K221244 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 25, 2022 | K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 18, 2022 | K220131 | KYPHON VuE Bone Cement | NDN | Substantially Equivalent | Tecres S.P.A. | accessdata.fda.gov |
| April 12, 2022 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| February 9, 2022 | 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 | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 13, 2021 | K212428 | Centerpiece Plate Fixation System | NQW | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 8, 2021 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 19, 2021 | K212653 | Catalyft LS Expandable Interbody System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 21, 2021 | K211958 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| June 23, 2021 | K211596 | CD Horizon Spinal System | OLO | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 24, 2021 | K210425 | Catalyft PL Expandable Interbody System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 30, 2021 | K210637 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| January 15, 2021 | K203678 | CD HORIZON Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 10, 2020 | K201407 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 8, 2020 | K202328 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 26, 2020 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 19, 2020 | K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement | PML | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| January 8, 2020 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device | OVD | Substantially Equivalent | Titan Spine, Inc. | accessdata.fda.gov |
| November 22, 2019 | K192336 | Navigated Anterolateral Disc Prep Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 15, 2019 | K190840 | Medtronic Transportation / Sterilization Cassettes | KCT | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 3, 2019 | K191066 | CD Horizon Astute Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 12, 2019 | K191148 | Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set | PML | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 29, 2019 | K192054 | Endoskeleton TAS Plate | OVD | Substantially Equivalent | Titan Spine, Inc. | accessdata.fda.gov |
| August 26, 2019 | K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 16, 2019 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device | ODP | Substantially Equivalent | Titan Spine, Inc. | accessdata.fda.gov |
| August 6, 2019 | K191565 | Endoskeleton TCS Interbody Fusion Device | OVE | Substantially Equivalent | Titan Spine, Inc. | accessdata.fda.gov |
| May 6, 2019 | K190165 | Capstone Control Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 4, 2019 | K183197 | PYRAMESH Implant System | MQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 11, 2019 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device | ODP | Substantially Equivalent | Titan Spine, Inc. | accessdata.fda.gov |
| January 16, 2019 | K183510 | T2 STRATOSPHERE Expandable Corpectomy System | MQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 11, 2019 | K182928 | CD Horizon Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 2, 2019 | K181864 | Polaris RF Ablation System | GXD | Substantially Equivalent | Baylis Medical Company, Inc. | accessdata.fda.gov |
| November 2, 2018 | K182121 | CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 4, 2018 | K182436 | POWEREASE System | HBE | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 19, 2018 | K181328 | T2 STRATOSPHERE Expandable Corpectomy System | MQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 29, 2018 | K182119 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 17, 2018 | K181111 | Navigated INFINITY Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 18, 2018 | K180851 | VERTEX Reconstruction System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| March 8, 2018 | K173249 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 13, 2018 | K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device | ODP | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| January 18, 2018 | K173338 | Navigated INFINITY Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 20, 2017 | K173125 | T2 STRATOSPHERE Expandable Corpectomy System | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| November 2, 2017 | K172328 | SOVEREIGN Spinal System | OVD | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 5, 2017 | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 26, 2017 | K171107 | CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 19, 2017 | K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 21, 2017 | K163375 | INFINITY OCT System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 6, 2017 | K171031 | CRESCENT Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| July 6, 2017 | K170399 | Endoskeleton TO Interbody Fusion Device (IBD) | MAX | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| June 13, 2017 | K171468 | FUSE Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| May 16, 2017 | K163181 | TRANSLACE Spinal Tethering System | OWI | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 11, 2017 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| April 14, 2017 | K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 13, 2017 | K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device | OVD | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| December 20, 2016 | K163301 | CD HORIZON® Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 14, 2016 | K162680 | SOVEREIGN® Spinal System | OVD | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 16, 2016 | K162379 | CD HORIZON® Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 4, 2016 | K162494 | CD HORIZON® Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 12, 2016 | K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems | OUR | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| March 7, 2016 | K160418 | PERIMETER Interbody Fusion Device | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| March 2, 2016 | K153438 | PERIMETER C (Titanium) Spinal System | ODP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 18, 2016 | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 10, 2016 | K153589 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 20, 2016 | K152241 | Medtronic Transportation/Sterilization Cassettes | KCT | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 6, 2016 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | PML | Substantially Equivalent | Medtronic Sofamor Danek USA, Incorporated | accessdata.fda.gov |
| December 30, 2015 | K153463 | CD HORIZON Spinal System, IPC POWEREASE System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 14, 2015 | K153122 | Endoskeleton(r) TCS System | OVE | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| November 24, 2015 | K152057 | OsteoCool V-3 RF Ablation System | GEI | Substantially Equivalent | Baylis Medical Company, Inc. | accessdata.fda.gov |
| November 16, 2015 | K151227 | KYPHON XPEDE Bone Cement | NDN | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| November 13, 2015 | K152277 | PIVOX(tm) Oblique Lateral Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 12, 2015 | K152623 | ATLANTIS Anterior Cervical Plate System | KWQ | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 5, 2015 | K152248 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 27, 2015 | K152457 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 9, 2015 | K151596 | Endoskeleton TCS Interbody Fusion Device | OVE | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| August 14, 2015 | K151172 | MASTERGRAFT Contain | MQV | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 23, 2015 | K151532 | KYPHON ELEMENT Inflatable Bone Tamp | HRX | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 16, 2015 | K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| June 11, 2015 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| June 9, 2015 | K142559 | ELEVATE Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 8, 2015 | K143019 | CD HORIZON Spinal System, IPC POWEREASE System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 25, 2015 | K150200 | CD HORIZON Growth Rod Conversion Set | PGM | Substantially Equivalent | Medtronic Sofamor Danek USA, Incorporated | accessdata.fda.gov |
| February 13, 2015 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 12, 2015 | K143628 | Navigated Vertex Select Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 12, 2015 | K143569 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 24, 2014 | P090029 | PRESTIGE LP CERVICAL DISC | MJO | 20 | August 9, 2024 | accessdata.fda.gov |
| May 12, 2009 | P060023 | BRYAN CERVICAL DISC PROSTHESIS | MJO | 7 | March 18, 2020 | accessdata.fda.gov |
| July 16, 2007 | P060018 | PRESTIGE CERVICAL DISC SYSTEM | MJO | 5 | August 11, 2016 | accessdata.fda.gov |
| March 9, 2007 | P050053 | INFUSE BONE GRAFT | NPZ | 63 | August 26, 2026 | accessdata.fda.gov |
| November 21, 2005 | P040001 | X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM | NQO | 19 | December 12, 2014 | accessdata.fda.gov |
| April 30, 2004 | P000054 | INFUSE BONE GRAFT | MPW | 72 | August 26, 2026 | accessdata.fda.gov |
| July 2, 2002 | P000058 | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE | NEK | 90 | August 26, 2026 | accessdata.fda.gov |
| June 13, 2002 | P000028 | AFFINITY (TM) CAGE SYSTEM | MAX | 7 | July 25, 2006 | accessdata.fda.gov |
| May 14, 1999 | P970015 | INTER FIX THREADED FUSION DEVICE | MAX | 22 | July 27, 2005 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 12, 2026 | 99701 | Class II | Ongoing | Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling pr | Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested p | accessdata.fda.gov |
| September 16, 2025 | 97714 | Class II | Ongoing | 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: 60 | 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. | accessdata.fda.gov |
| September 26, 2023 | 93163 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 31, 2023 | 92846 | Class II | Ongoing | 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. | accessdata.fda.gov |
| June 6, 2023 | 92567 | Class II | Ongoing | 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 | accessdata.fda.gov |
| February 16, 2023 | 91790 | Class II | Ongoing | 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 inst | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws | accessdata.fda.gov |
| February 8, 2023 | 91697 | Class II | Ongoing | Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S431 | 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. | accessdata.fda.gov |
| November 19, 2021 | 92142 | Class II | Ongoing | Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery | Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor. | accessdata.fda.gov |
| September 2, 2021 | 88684 | Class II | Terminated | Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm | Engraving on implants may not match what is listed on the pouch labels. | accessdata.fda.gov |
| June 8, 2020 | 85904 | Class II | Terminated | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | accessdata.fda.gov |
| April 24, 2020 | 85611 | Class II | Terminated | Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, | accessdata.fda.gov |
| March 26, 2020 | 85414 | Class II | Terminated | VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 | Nonconforming product; length of the product measured shorter than the labeled length. | accessdata.fda.gov |
| September 27, 2018 | 81171 | Class II | Terminated | INFUSE Bone Graft X SMALL KIT REF 7510100 | The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS. | accessdata.fda.gov |
| July 9, 2018 | 80541 | Class II | Terminated | Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, RE | This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements. | accessdata.fda.gov |
| March 23, 2018 | 79792 | Class II | Terminated | Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body | Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm. | accessdata.fda.gov |
| March 13, 2018 | 79667 | Class II | Terminated | Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for | The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage. | accessdata.fda.gov |
| December 22, 2017 | 78839 | Class II | Terminated | Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only | Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification. | accessdata.fda.gov |
| December 6, 2017 | 78790 | Class II | Terminated | Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R | Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument. | accessdata.fda.gov |
| May 17, 2017 | 77352 | Class II | Terminated | KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R. | The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon. | accessdata.fda.gov |
| April 13, 2017 | 77049 | Class II | Terminated | Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only | Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle. | accessdata.fda.gov |
| February 20, 2017 | 76694 | Class II | Terminated | Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MP | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | accessdata.fda.gov |
| July 18, 2016 | 74850 | Class II | Terminated | RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R | The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. | accessdata.fda.gov |
| January 13, 2015 | 70414 | Class II | Terminated | KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices. | The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments. | accessdata.fda.gov |
| December 3, 2014 | 70032 | Class II | Terminated | POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent. | The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw. | accessdata.fda.gov |
| January 6, 2014 | 67267 | Class II | Terminated | Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void | Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm. | accessdata.fda.gov |
| January 3, 2014 | 67203 | Class II | Terminated | SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument. | The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw. | accessdata.fda.gov |
| August 12, 2013 | 66010 | Class II | Terminated | T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal sur | One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip. | accessdata.fda.gov |
| May 28, 2013 | 65297 | Class II | Terminated | INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. | accessdata.fda.gov |
| August 30, 2012 | 63157 | Class II | Terminated | ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precisio | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. | accessdata.fda.gov |
| March 13, 2012 | 61453 | Not yet classified | Terminated | ATLANTIS(TM) Anterior Cervical Plate System Adjustable Drill Stop, REF, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 Product Usage: Manual orthopedic adjustable dri | Drill stops may be bypassed when the device is used with powered drilling instruments. | accessdata.fda.gov |
| November 30, 2011 | 60568 | Not yet classified | Terminated | CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 implant | One screw may be longer then size etched on the screw. | accessdata.fda.gov |
| July 12, 2011 | 59375 | Not yet classified | Terminated | TSRH(R) Spinal System SCREW, REF, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: 1 EA, Medtronic Sofamor Danek USA. Product Usage: TSRH(R) Spinal System is intended to help provide immobilization of spinal segm | Screws are 5 mm longer than the size etched on the screw. | accessdata.fda.gov |
| July 6, 2011 | 59221 | Not yet classified | Terminated | ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Tapping Variable Screw Caddy ). Medtronic Sofamor Danek USA, Inc. This instrument is a precision device which incorporates a measuring function. | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. | accessdata.fda.gov |
| June 28, 2011 | 59021 | Not yet classified | Terminated | CD HORIZON (R) LEGACY (TM) FAS, REF 7542535, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilization of spinal segments as an a | Screws are longer then size etched on the screw. | accessdata.fda.gov |
| December 7, 2009 | 54031 | Not yet classified | Terminated | Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON LEGACY" Percutaneous Peek Spinal System | The Trocar may not fully engage with the Rod Inserter or may prematurely disengage. | accessdata.fda.gov |
| February 6, 2009 | 52125 | Not yet classified | Terminated | Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STERILE R. The INTREPID | The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment. | accessdata.fda.gov |
| November 12, 2007 | 46735 | Not yet classified | Terminated | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901000, 10mm, 5.5mm dia x 100mm, size: 10mm x 100mm, for spinal fixation. | Breaks: Shear failure of the cable component of the system. | accessdata.fda.gov |
| September 13, 2007 | 44967 | Not yet classified | Terminated | Satellite Spinal System Primary User Group Reference Guide, 8 1/2 by 11 inch plastic binder, Medtronic Sofamor Danek, Medtronic, Memphis, TN 38132 | Surgical manual lacks information required as a condition of the 510(k) approval. | accessdata.fda.gov |
| September 4, 2007 | 44953 | Not yet classified | Terminated | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, SIZE 6 X 12, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA | Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated. | accessdata.fda.gov |
| August 24, 2007 | 44787 | Not yet classified | Terminated | Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131 | Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws. | accessdata.fda.gov |
| February 2, 2007 | 37376 | Not yet classified | Terminated | Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only, manufactured at: Warsaw, Indiana USA, Rx only | Bone screws may pull though the plate. | accessdata.fda.gov |
| October 20, 2006 | 36701 | Not yet classified | Terminated | Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111 | Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use. | accessdata.fda.gov |
| January 14, 2006 | 35261 | Not yet classified | Terminated | 8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral stabilization/fusion) | Device distribution without marketing clearance | accessdata.fda.gov |
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Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.