PhysioStim and SpinalStim
FDA premarket approval P850007/S041 · decided 2019-06-18
Approval details
- PMA number
- P850007
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PhysioStim and SpinalStim
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2019-04-15
- Decision date
- 2019-06-18
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Approval for software and firmware updates to the SpinalStim. CervicalStim, and PhysioStim devices. The updates made are identical to each devices, and include modifications to the mobile medical phone application
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