MOBI-C CERVICAL DISC PROSTHESIS
FDA premarket approval P110002/S009 · decided 2015-02-05
Approval details
- PMA number
- P110002
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MOBI-C CERVICAL DISC PROSTHESIS
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2014-12-08
- Decision date
- 2015-02-05
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- APPROVAL FOR MODIFICATIONS MADE TO THE MOBI-C UNIVERSAL INSERTERINSTRUMENT, WHICH INCLUDED ADDITION OF MATERIAL TO INCREASE THE INNER DIAMETER AND A CHANGE TO THE LASER MARKING AND PASSIVATION PROCESS.
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