LDR Spine Mobi-C Cervical Disc Prosthesis (One Level)
FDA premarket approval P110002/S021 · decided 2018-05-15
Approval details
- PMA number
- P110002
- Supplement
- S021
- Supplement type
- 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
- 2018-04-17
- Decision date
- 2018-05-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- Update the cutting fluid and bactericidal agent for the machines used to manufacture Mobi-C components.
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|---|---|---|
| Vital™ Spinal Fixation System (K253093) | Highridge Medical, LLC | 2025-12-17 |
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