SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
FDA premarket approval P900009 · decided 1994-10-05
Approval details
- PMA number
- P900009
- Trade name
- SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Bioventus, LLC
- Date received
- 1990-02-01
- Decision date
- 1994-10-05
- Days to decision
- 1707 days
- Decision code
- APRL
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| StimTrial Neuromodulation System (K243782) | Bioventus, LLC | 2025-07-16 |
| TalisMann Neuromodulation System (K243678) | Bioventus, LLC | 2025-07-03 |
| Allograft Delivery Device (OFAC-C) (K233368) | Bioventus, LLC | 2024-06-25 |
| SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty (K233490) | Bioventus, LLC | 2023-12-05 |
| MCS Bone Graft (K162860) | Bioventus, LLC | 2017-02-13 |