MOBI-C CERVICAL DISC PROSTHESIS
FDA premarket approval P110002/S010 · decided 2015-10-06
Approval details
- PMA number
- P110002
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- MOBI-C CERVICAL DISC PROSTHESIS
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2015-04-06
- Decision date
- 2015-10-06
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- APPROVAL FOR MODIFICATIONS TO THE MOBI-C LABELING.
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