CERVICAL STIM
FDA premarket approval P030034/S002 · decided 2009-07-10
Approval details
- PMA number
- P030034
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CERVICAL STIM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2009-05-07
- Decision date
- 2009-07-10
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- APPROVAL FOR THE RELOCATION AND CHANGE OF THE CHARGE MANAGEMENT CONTROLLER AND THE REPLACEMENT OF THE CHARGER UNIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERVICAL-STIM CERVICAL FUSION SYSTEM AND IS INDICATED AS AN ADJUNCT TO CERVICAL FUSION SURGERY IN PATIENTS AT HIGH RISK FOR NON-FUSION.
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