Mobi-C Cervical Disc Prosthesis
FDA premarket approval P110002/S020 · decided 2018-05-30
Approval details
- PMA number
- P110002
- Supplement
- S020
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Mobi-C Cervical Disc Prosthesis
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2018-01-05
- Decision date
- 2018-05-30
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- Approval for an update of labeling with 84 month data.
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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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