CervicalStim
FDA premarket approval P030034/S010 · decided 2017-06-22
Approval details
- PMA number
- P030034
- Supplement
- S010
- 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
- 2017-03-24
- Decision date
- 2017-06-22
- Days to decision
- 90 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 and CervicalStim devices. The updates made are identical to both devices, and include modifications to the user display and mobile medical phone application
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