MNF · Implant, Temporal
General, Plastic Surgery · 21 CFR 878.3550 · Class 2
Overview
| Product Code | MNF |
|---|---|
| Device Name | Implant, Temporal |
| Regulation | 21 CFR 878.3550 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K111069 | OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT | Osteosymbionics, LLC | Sep 22, 2011 | SESE |
| K002586 | MEDPOR PTERIONAL SURGICAL IMPLANT | Porex Surgical Products Group | Nov 17, 2000 | SESE |
Top Applicants
- Porex Surgical Products Group — 1 clearance
- Osteosymbionics, LLC — 1 clearance
