SpinalStim
FDA premarket approval P850007/S042 · decided 2019-07-03
Approval details
- PMA number
- P850007
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SpinalStim
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2019-06-07
- Decision date
- 2019-07-03
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Modification in the verification step for the coil winding procedure and to add equipment to cut and split the ribbon cable to the desired specifications.
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