CERVICAL-STIM CERVICAL FUSION SYSTEM
FDA premarket approval P030034/S001 · decided 2005-05-16
Approval details
- PMA number
- P030034
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CERVICAL-STIM CERVICAL FUSION SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2005-02-14
- Decision date
- 2005-05-16
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
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