MOBI-C CERVICAL DISC PROSTHESIS
FDA premarket approval P110009/S012 · decided 2015-06-30
Approval details
- PMA number
- P110009
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MOBI-C CERVICAL DISC PROSTHESIS
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2015-06-05
- Decision date
- 2015-06-30
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- APPROVAL FOR CLARIFICATIONS IN THE SURGICAL TECHNIQUE MANUAL.
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