CervicalStim
FDA premarket approval P030034/S011 · decided 2018-03-07
Approval details
- PMA number
- P030034
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CervicalStim
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2017-12-07
- Decision date
- 2018-03-07
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Approval for updates to the STIM onTrack mobile application for compatibility with Android OS. The optional mobile application is identical in functionality to the previously approved iOS version. The application is compatible with the CervicalStim Model 5505, SpinalStim Model 5212, and PhysioStim Models 5302, 5303, 5313, 5314, and 5315.
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