LDR Spine Mobi-C Cervical Disc Prosthesis
FDA premarket approval P110002/S036 · decided 2024-12-02
Approval details
- PMA number
- P110002
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LDR Spine Mobi-C Cervical Disc Prosthesis
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2024-09-05
- Decision date
- 2024-12-02
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- This supplement requested approval for extending shelf life of the LDR Spine Mobi-C® Cervical Disc Prosthesis from 5 years to 10 years.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |