Exogen
FDA premarket approval P900009/S048 · decided 2022-01-07
Approval details
- PMA number
- P900009
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Exogen
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Bioventus, LLC
- Date received
- 2021-12-03
- Decision date
- 2022-01-07
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Use an additional supplier for the plastic housing components of the Main Operating Unit of the EXOGEN® Ultrasound Bone Healing System.
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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 |