ODU · Facial Implant
General, Plastic Surgery · 21 CFR 878.3500 · Class 2
Overview
| Product Code | ODU |
|---|---|
| Device Name | Facial Implant |
| Regulation | 21 CFR 878.3500 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K071823 | PERMA FACIAL IMPLANTS | Surgisil | Sep 19, 2007 | SESE |
Top Applicants
- Surgisil — 1 clearance
