MOBI-C CERVICAL DISC PROTHESIS
FDA premarket approval P110009/S001 · decided 2014-05-19
Approval details
- PMA number
- P110009
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- MOBI-C CERVICAL DISC PROTHESIS
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2013-09-12
- Decision date
- 2014-05-19
- Days to decision
- 249 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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510(k) clearances by this applicant
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|---|---|---|
| Vital™ Spinal Fixation System (K253093) | Highridge Medical, LLC | 2025-12-17 |
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