SpinalStim
FDA premarket approval P850007/S044 · decided 2020-03-27
Approval details
- PMA number
- P850007
- Supplement
- S044
- 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
- 2020-02-26
- Decision date
- 2020-03-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Implementing an alternative machine to produce the devices transducer coil.
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