MOBI-C CERVICAL DISC PROSTHESIS (ONE LEVEL)
FDA premarket approval P110002/S005 · decided 2014-07-15
Approval details
- PMA number
- P110002
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- MOBI-C CERVICAL DISC PROSTHESIS (ONE LEVEL)
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2014-03-28
- Decision date
- 2014-07-15
- Days to decision
- 109 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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