SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
FDA premarket approval P900009/S002 · decided 1996-04-02
Approval details
- PMA number
- P900009
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 1995-12-15
- Decision date
- 1996-04-02
- Days to decision
- 109 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY WHICH IS OWNED AND OPERATED BY HI-TRONICS DESIGNS, INC. AND LOCATED AT 999 WILLOW GROVE ST., BUILDING 2, SUITES 4A, 4B AND 18E, HACKETTSTOWN, NJ 07840. THE SAFHS MODEL 2A WILL BE MANUFACTURED AT THIS SITE
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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 |