Promethean Restorative, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252962 | DYNAMIS Navigation System | January 12, 2026 |
| K251075 | DYNAMIS Implant System | April 25, 2025 |
| K243565 | DYNAMIS SI Screw System | February 28, 2025 |