Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3680](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3680) → FZE — Prosthesis, Nose, Internal

# FZE · Prosthesis, Nose, Internal

_General, Plastic Surgery · 21 CFR 878.3680 · Class 2_

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

## Overview

- **Product Code:** FZE
- **Device Name:** Prosthesis, Nose, Internal
- **Regulation:** [21 CFR 878.3680](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3680)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

## Classification Rationale

Class II.

## Recent Cleared Devices (20 of 42)

Showing 20 most recent of 42 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K241253](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K241253.md) | Medicon Epiplating System | Cmf Medicon Surgical, Inc. | Dec 12, 2024 | SESE |
| [K161548](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K161548.md) | Osseointegrated Fixtures | Southern Implants (Pty), Ltd. | Dec 1, 2016 | SESE |
| [K090803](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K090803.md) | HANSON MEDICAL FACIAL IMPLANTS | Hanson Medical, Inc. | Jun 30, 2010 | SESE |
| [K090630](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K090630.md) | NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) | Nobel Biocare AB | Jun 2, 2009 | SESE |
| [K071018](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K071018.md) | MONARCH NASAL IMPLANT | Hanson Medical, Inc. | May 25, 2007 | SESE |
| [K041690](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K041690.md) | MONARCH NASAL IMPLANT | Hanson Medical, Inc. | Feb 11, 2005 | SESE |
| [K021418](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K021418.md) | AART NASAL IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | Jul 2, 2002 | SESE |
| [K992242](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K992242.md) | PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS | Pillar Surgical, Inc. | Nov 22, 1999 | SESE |
| [K983755](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K983755.md) | NASAL DORSAL SERIES | Surgical Technology Laboratories, Inc. | Nov 20, 1998 | SESE |
| [K982753](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K982753.md) | SEARE BIOMEDICAL NASAL IMPLANTS | Seare Biomedical Corp. | Sep 30, 1998 | SESE |
| [K981833](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K981833.md) | SILIMED NASAL L SHAPED IMPLANT | Silimed, LLC | Jun 26, 1998 | SESE |
| [K973573](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K973573.md) | DURALASTIC ANATOMICAL NASAL IMPLANTS | Hanson Medical, Inc. | Nov 13, 1997 | SESE |
| [K971481](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K971481.md) | DURALASTIC ANATOMICAL NASAL IMPLANTS | Allied Biomedical Corp. | Jul 18, 1997 | SESE |
| [K962824](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K962824.md) | IMPLANTECH JEJ PERI-PYRIFORM IMPLANT | Implantech Associates, Inc. | Oct 3, 1996 | SESE |
| [K961124](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K961124.md) | THE NAUTILUS | Rand Scientific Corp. | Apr 19, 1996 | SESE |
| [K952709](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K952709.md) | PROTHESIS, CHIN, INTERNAL | Spirit Ridge Technologies | Aug 28, 1995 | SESE |
| [K952708](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K952708.md) | PECTORALIS IMPLANT | Spirit Ridge Technologies | Aug 28, 1995 | SESE |
| [K952707](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K952707.md) | SILICONE ELASTOMER MALAR IMPLANT | Spirit Ridge Technologies | Aug 28, 1995 | SESE |
| [K952706](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K952706.md) | SPIRIT RIDGE SILICONE CARVING BLOCK | Spirit Ridge Technologies | Aug 28, 1995 | SESE |
| [K952705](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K952705.md) | SPIRIT RIDGE NASAL IMPLANT | Spirit Ridge Technologies | Aug 28, 1995 | SESE |

## Top Applicants

- Implantech Associates, Inc. — 7 clearances
- Spirit Ridge Technologies — 5 clearances
- Hanson Medical, Inc. — 4 clearances
- Byron Medical — 3 clearances
- Cui Corp. — 2 clearances

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

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