THE MOBI-C CERVICAL DISC PROSTHESIS
FDA premarket approval P110002/S011 · decided 2016-01-27
Approval details
- PMA number
- P110002
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE MOBI-C CERVICAL DISC PROSTHESIS
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2015-04-20
- Decision date
- 2016-01-27
- Days to decision
- 282 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- APPROVAL FOR LARGER MOBI-C® ENDPLATE FOOTPRINTS.
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