MOBI-C CERVICAL DISC PROTHESIS
FDA premarket approval P110009/S003 · decided 2013-12-18
Approval details
- PMA number
- P110009
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Trade name
- MOBI-C CERVICAL DISC PROTHESIS
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2013-11-18
- Decision date
- 2013-12-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- TOOL CHANGE FOR THE MILLING OF THE INFERIOR ENDPLATE.
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 |