MOBI-C CERVICAL DISC PROSTHESIS
FDA premarket approval P110002/S002 · decided 2014-06-03
Approval details
- PMA number
- P110002
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- MOBI-C CERVICAL DISC PROSTHESIS
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2013-09-12
- Decision date
- 2014-06-03
- Days to decision
- 264 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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|---|---|---|
| Vital™ Spinal Fixation System (K253093) | Highridge Medical, LLC | 2025-12-17 |
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