MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
FDA premarket approval P110009/S015 · decided 2017-05-05
Approval details
- PMA number
- P110009
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2016-09-30
- Decision date
- 2017-05-05
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- Approval for manufacturing sites located at: 1) SAS Etablissements Maurice, MARLE, Zi Rue Lavoisier, Bp 46, Nogent France; 2) Marie Finishing SAS, 22 Rue de IaMollanche Sorbiers, Loire 42290, France; and 3) Marie Sferic SAS, Zone Artisanale, Rue du Courtois Prolongee 41500 MENARS France, for polishing endplates and machining the mobile insert of the device.
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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 |