Mobi-C® Cervical Disc Prosthesis (one-level use)
FDA premarket approval P110002/S031 · decided 2021-11-01
Approval details
- PMA number
- P110002
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Mobi-C® Cervical Disc Prosthesis (one-level use)
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2021-10-05
- Decision date
- 2021-11-01
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- Manufacturing changes to the outer layer of the inner pouch of the packaging for the Mobi-C implant.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Vital™ Spinal Fixation System (K253093) | Highridge Medical, LLC | 2025-12-17 |
| Virage® OCT Spinal Fixation System (K250332) | Highridge Medical, LLC | 2025-04-04 |