Product areas
FDA product code distribution
Medtronic Sofamor Danek USA, Inc.
Country / Region:United States (US)
510(k) submissions
5
Filtered: GEI
Latest clearance
2026-06-05
Product codes
2
OLO, GEI
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
1 manufacturers
- 2
Citing manufacturers
Companies that cited this company's devices as predicates
2 manufacturers
- 5
- 2