MPI · Glenoid Fossa Prosthesis
Dental · 21 CFR 872.3950 · Class 3
Overview
| Product Code | MPI |
|---|---|
| Device Name | Glenoid Fossa Prosthesis |
| Regulation | 21 CFR 872.3950 |
| Device Class | Class 3 |
| Review Panel | Dental |
| Implant | Yes |
Identification
A glenoid fossa prosthesis is a device that is intended to be implanted in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular condyle.
Classification Rationale
Class III.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P000035 | TMJ FOSSA-EMINENCE PROSTHESIS(TM) | Nexus CMF, LLC | Feb 27, 2001 | APPR |
Top Applicants
- Nexus CMF, LLC — 1 clearance
