Fusion Innovations, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 2
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252661 | SternaFuse Ti Fixation System | November 19, 2025 |
| K202914 | SternaFuse Fixation System | January 26, 2022 |