Medtronic Sofamor Danek
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 253
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251193 | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft | June 12, 2025 |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | January 17, 2025 |
| K230716 | Robotic Graft Delivery Instruments | July 18, 2023 |
| K212428 | Centerpiece Plate Fixation System | December 13, 2021 |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | August 26, 2020 |
| K173125 | T2 STRATOSPHERE Expandable Corpectomy System | December 20, 2017 |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Ti | September 19, 2017 |
| K171031 | CRESCENT Spinal System | July 6, 2017 |
| K171468 | FUSE Spinal System | June 13, 2017 |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, M | May 11, 2017 |
| K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) S | August 12, 2016 |
| K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody D | January 19, 2016 |
| K141824 | MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP | September 5, 2014 |
| K140417 | DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM | July 9, 2014 |
| K140449 | CD HORIZON SPINAL SYSTEM | March 25, 2014 |
| K140276 | CD HORIZON SPINAL SYSTEM | March 13, 2014 |
| K132897 | CLYDESDALE SPINAL SYSTEM | December 11, 2013 |
| K133216 | CRESCENT SPINAL SYSTEM | November 22, 2013 |
| K132700 | PERIMETER INTERBODY FUSION DEVICE | September 26, 2013 |
| K131888 | T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE | September 23, 2013 |