Product areas
FDA product code distribution
Medtronic Sofamor Danek USA, Inc.
Country / Region:United States (US)
510(k) submissions
2
Filtered: GEI
Latest clearance
2026-06-05
Product codes
2
GEI, OLO
510(k) submissions
1 total · filtered by GEI
Showing 1–1
| 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 |
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
No predicate manufacturers found
This company has not cited predicate devices with known manufacturers yet
Citing manufacturers
Companies that cited this company's devices as predicates
1 manufacturers
- 1