Exogen Ultrasound Bone Healing System
FDA premarket approval P900009/S044 · decided 2019-12-20
Approval details
- PMA number
- P900009
- Supplement
- S044
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Exogen Ultrasound Bone Healing System
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Bioventus, LLC
- Date received
- 2019-06-25
- Decision date
- 2019-12-20
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Approval for modified indications for use to include adjunctive use in patients with internal or external fracture fixation hardware present, patients undergoing treatment for infection at the fracture site, and patients believed to have diminished bone quality.
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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 |