Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3590](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3590) → FZD — Prosthesis, Ear, Internal

# FZD · Prosthesis, Ear, Internal

_General, Plastic Surgery · 21 CFR 878.3590 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD

## Overview

- **Product Code:** FZD
- **Device Name:** Prosthesis, Ear, Internal
- **Regulation:** [21 CFR 878.3590](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3590)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **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](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD/K172389.md) | ePTFE-Coated Auricular Implant | Implantech Associates, Inc. | Jul 18, 2018 | SESE |
| [K863939](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD/K863939.md) | POREX(TM) EAR PROSTHESIS | Porex Medical | Oct 24, 1986 | SESE |
| [K844960](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD/K844960.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD)

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