EXOGEN 4000+ BONE HEALING SYSTEM
FDA premarket approval P900009/S030 · decided 2009-03-13
Approval details
- PMA number
- P900009
- Supplement
- S030
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXOGEN 4000+ BONE HEALING SYSTEM
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2008-12-23
- Decision date
- 2009-03-13
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE MANUFACTURING OF THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA).
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510(k) clearances by this applicant
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|---|---|---|
| StimTrial Neuromodulation System (K243782) | Bioventus, LLC | 2025-07-16 |
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| 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 |