Medtronic Sofamor Danek USA, Inc.
FDA 510(k) & PMA Approved Devices — 79 products
Total Devices79
Categories19
Latest FDA decision2026-07-28
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K231184 | CD Horizon™ Spinal System | OLO | 2023-05-26 | View |
| 510(k) | K223764 | INFINITY OCT System | NKG | 2023-01-11 | View |
| 510(k) | K223153 | Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology | MAX | 2022-12-16 | View |
| 510(k) | 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 | 2022-10-04 | View |
| 510(k) | K222383 | Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition | OLO | 2022-09-29 | View |
| 510(k) | K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments | OLO | 2022-05-25 | View |
| 510(k) | 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 | 2022-02-09 | View |
| 510(k) | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | MAX | 2021-12-08 | View |
| 510(k) | K212653 | Catalyft LS Expandable Interbody System | MAX | 2021-11-19 | View |
| 510(k) | K211958 | CD Horizon Spinal System | NKB | 2021-07-21 | View |
| 510(k) | K211441 | Navigated Anterolateral Disc Prep Instruments | OLO | 2021-06-09 | View |
| 510(k) | 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 | 2021-05-26 | View |
| 510(k) | K210425 | Catalyft PL Expandable Interbody System | MAX | 2021-05-24 | View |
| 510(k) | K203678 | CD HORIZON™ Spinal System | NQP | 2021-01-15 | View |
| 510(k) | K203291 | CD Horizon Spinal System Instruments | OLO | 2020-12-08 | View |
| 510(k) | K201407 | CD Horizon™ Spinal System | NKB | 2020-09-10 | View |
| 510(k) | K202328 | CD Horizon Spinal System | NKB | 2020-09-08 | View |
| 510(k) | K191788 | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | MAX | 2020-03-23 | View |
| 510(k) | 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 | 2020-01-22 | View |
| 510(k) | K193011 | CD Horizon™ Fenestrated Screw Set | NKB | 2020-01-10 | View |
No matching devices.
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