LDR Spine Mobi-C® Cervical Disc Prosthesis
FDA premarket approval P110002/S035 · decided 2023-08-01
Approval details
- PMA number
- P110002
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LDR Spine Mobi-C® Cervical Disc Prosthesis
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2023-02-06
- Decision date
- 2023-08-01
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- Approval for the addition of H4.5mm inserts to the Mobi-C® Cervical Disc Prosthesis System.
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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 |