Product areas
FDA product code distribution
Medtronic Sofamor Danek USA, Inc.
Country / Region:United States (US)
510(k) submissions
5 total
Showing 1–5
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | GEI | Class 2 | 2026-06-05 |
| K231184 | CD Horizon™ Spinal System | OLO | Class 2 | 2023-05-26 |
| K222383 | Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition | OLO | Class 2 | 2022-09-29 |
| K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments | OLO | Class 2 | 2022-05-25 |
| 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 | Class 2 | 2022-02-09 |
Company profile
- Canonical name
- Medtronic Sofamor Danek USA, Inc.
- Country / Region
- United States(US)
- Address
- 1800 Pyramid Pl. Memphis, TN 38132
Predicate manufacturers
Companies whose devices this company cited as predicates
1 manufacturers
- 2
Citing manufacturers
Companies that cited this company's devices as predicates
2 manufacturers
- 5
- 2