FZD · Prosthesis, Ear, Internal
General, Plastic Surgery · 21 CFR 878.3590 · Class 2
Overview
| Product Code | FZD |
|---|---|
| Device Name | Prosthesis, Ear, Internal |
| Regulation | 21 CFR 878.3590 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.
Classification Rationale
Class II.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172389 | ePTFE-Coated Auricular Implant | Implantech Associates, Inc. | Jul 18, 2018 | SESE |
| K863939 | POREX(TM) EAR PROSTHESIS | Porex Medical | Oct 24, 1986 | SESE |
| K844960 | CANAL WALL PROSTHESIS | Richards Medical Co., Inc. | Feb 26, 1985 | SESE |
Top Applicants
- Richards Medical Co., Inc. — 1 clearance
- Porex Medical — 1 clearance
- Implantech Associates, Inc. — 1 clearance
