PhysioStim and SpinalStim
FDA premarket approval P850007/S043 · decided 2019-10-08
Approval details
- PMA number
- P850007
- Supplement
- S043
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PhysioStim and SpinalStim
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2019-09-16
- Decision date
- 2019-10-08
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Modify the manufacturing process for sewing the garment assembly for the Orthofix SpinalStim Model 5212 and modify the manufacturing process to cut, split, and strip the ribbon cable for the Orthofix CervicalStim Model 5505 and Orthofix PhysioStim Models 53XX.
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