LDR Spine Mobi-C Cervical Disc Prosthesis (One Level)
FDA premarket approval P110002/S033 · decided 2023-01-12
Approval details
- PMA number
- P110002
- Supplement
- S033
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LDR Spine Mobi-C Cervical Disc Prosthesis (One Level)
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2022-02-15
- Decision date
- 2023-01-12
- Days to decision
- 331 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- Approval for qualifying alternative detergents Deconex MT12 & MT13 used for cleaning of the Mobi-C implant and a sub-supplier change to KEYBIO.
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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 |