Bioventus, LLC
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 6
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0810-2021 | Class II | EXOGEN Ultrasound Coupling Gel | December 17, 2020 |
| Z-1148-2019 | Class II | BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voi | February 13, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K243782 | StimTrial Neuromodulation System | July 16, 2025 |
| K243678 | TalisMann Neuromodulation System | July 3, 2025 |
| K233368 | Allograft Delivery Device (OFAC-C) | June 25, 2024 |
| K233490 | SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty | December 5, 2023 |
| K193513 | SIGNAFUSE Bioactive Bone Graft | June 18, 2020 |
| K162860 | MCS Bone Graft | February 13, 2017 |