FZE · Prosthesis, Nose, Internal
General, Plastic Surgery · 21 CFR 878.3680 · Class 2
Overview
| Product Code | FZE |
|---|---|
| Device Name | Prosthesis, Nose, Internal |
| Regulation | 21 CFR 878.3680 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 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 | Medicon Epiplating System | Cmf Medicon Surgical, Inc. | Dec 12, 2024 | SESE |
| K161548 | Osseointegrated Fixtures | Southern Implants (Pty), Ltd. | Dec 1, 2016 | SESE |
| K090803 | HANSON MEDICAL FACIAL IMPLANTS | Hanson Medical, Inc. | Jun 30, 2010 | SESE |
| K090630 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) | Nobel Biocare AB | Jun 2, 2009 | SESE |
| K071018 | MONARCH NASAL IMPLANT | Hanson Medical, Inc. | May 25, 2007 | SESE |
| K041690 | MONARCH NASAL IMPLANT | Hanson Medical, Inc. | Feb 11, 2005 | SESE |
| K021418 | AART NASAL IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | Jul 2, 2002 | SESE |
| K992242 | PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS | Pillar Surgical, Inc. | Nov 22, 1999 | SESE |
| K983755 | NASAL DORSAL SERIES | Surgical Technology Laboratories, Inc. | Nov 20, 1998 | SESE |
| K982753 | SEARE BIOMEDICAL NASAL IMPLANTS | Seare Biomedical Corp. | Sep 30, 1998 | SESE |
| K981833 | SILIMED NASAL L SHAPED IMPLANT | Silimed, LLC | Jun 26, 1998 | SESE |
| K973573 | DURALASTIC ANATOMICAL NASAL IMPLANTS | Hanson Medical, Inc. | Nov 13, 1997 | SESE |
| K971481 | DURALASTIC ANATOMICAL NASAL IMPLANTS | Allied Biomedical Corp. | Jul 18, 1997 | SESE |
| K962824 | IMPLANTECH JEJ PERI-PYRIFORM IMPLANT | Implantech Associates, Inc. | Oct 3, 1996 | SESE |
| K961124 | THE NAUTILUS | Rand Scientific Corp. | Apr 19, 1996 | SESE |
| K952709 | PROTHESIS, CHIN, INTERNAL | Spirit Ridge Technologies | Aug 28, 1995 | SESE |
| K952708 | PECTORALIS IMPLANT | Spirit Ridge Technologies | Aug 28, 1995 | SESE |
| K952707 | SILICONE ELASTOMER MALAR IMPLANT | Spirit Ridge Technologies | Aug 28, 1995 | SESE |
| K952706 | SPIRIT RIDGE SILICONE CARVING BLOCK | Spirit Ridge Technologies | Aug 28, 1995 | SESE |
| K952705 | 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
- Surgical Technology Laboratories, Inc. — 2 clearances
