EXOGEN 2000/SONIC ACCELERATED FRACTURE HEALING SYSTEM
FDA premarket approval P900009/S011 · decided 2000-09-08
Approval details
- PMA number
- P900009
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- EXOGEN 2000/SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2000-07-11
- Decision date
- 2000-09-08
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR A CHANGE IN THE CONDITIONS OF APPROVAL TO TERMINATE THE REQUIREMENT FOR A PRESCRIPTION REGISTRY.
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 |