Osseofuse International, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 2
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243078 | HexaPLUS S OneDrill Implant System | October 10, 2025 |
| K181157 | Conical Plus Implant System | May 24, 2019 |