EXOGEN 2000+ LOW INTENSITY FRACTURE HEALING SYSTEM
FDA premarket approval P900009/S017 · decided 2003-04-22
Approval details
- PMA number
- P900009
- Supplement
- S017
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXOGEN 2000+ LOW INTENSITY FRACTURE HEALING SYSTEM
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2003-03-03
- Decision date
- 2003-04-22
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR THE ADDITION OF A NEW CIRCUIT BOARD INSPECTION STEP FOR THE EXOGEN 2000+ DEVICE.
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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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| SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty (K233490) | Bioventus, LLC | 2023-12-05 |
| MCS Bone Graft (K162860) | Bioventus, LLC | 2017-02-13 |