TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
FDA premarket approval P000035/S009 · decided 2014-06-02
Approval details
- PMA number
- P000035
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
- Generic name
- Glenoid fossa prosthesis
- Applicant
- Nexus CMF, LLC
- Date received
- 2014-03-04
- Decision date
- 2014-06-02
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MPI
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Golden, CO
- Statement
- APPROVAL FOR MODIFICATIONS TO THE BONE SCREW LENGTH TO MATCH THELABELED LENGTHS, TO STANDARDIZE THE SCREW THREAD PROFILE AND PITCH, TO INCREASE THE LENGTH OF THE THREADED PORTION OF THE BONE SCREW, TO ROUND THE TIP OF THE SCREW, TO ADD A FILLET BETWEEN THE SCREW HEAD AND SCREW SHAFT, TO STANDARDIZE DIMENSIONS OF CERTAIN GEOMETRICAL FEATURES OF THE BONE SCREWS (THE SCREW HEAD CROWN RADIUS AND DRIVER SLOT DEPTH), TO STANDARDIZE THE MINOR DIAMETER, AND TO INTRODUCE TI-6AL-4V ALLOY BONE SCREWS.
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