Prosthesis, Nose, Internal
FDA product code FZE · Class II (moderate risk) · 21 CFR 878.3680 · General, Plastic Surgery
42510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
- Implantech Associates, Inc. 7
- Spirit Ridge Technologies 5
- Hanson Medical, Inc. 4
- Byron Medical 3
- Surgical Technology Laboratories, Inc. 2
- Cui Corp. 2
- Cmf Medicon Surgical, Inc. 1
- Richard'S Medical Equip., Inc. 1
- Seare Biomedical Corp. 1
- Silimed, LLC 1
- Allied Biomedical Corp. 1
- Rand Scientific Corp. 1
- Nobelpharma USA, Inc. 1
- Smith & Nephew Richards, Inc. 1
- Applied Biomaterial Technologies 1
- Dow Corning Wright 1
- Omega Silicone, Inc. 1
- Porex Medical 1
- Cox-Uphuff Intl. 1
- Tekna Med Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241253 | Medicon Epiplating SystemFZE · Traditional | Cmf Medicon Surgical, Inc. | 12/12/2024SE |
| K161548 | Osseointegrated FixturesFZE · Traditional | Southern Implants (Pty), Ltd. | 12/01/2016SE |
| K090803 | Hanson Medical Facial ImplantsFZE · Traditional | Hanson Medical, Inc. | 06/30/2010SE |
| K090630 | Nobel Biocare Endosseous Implants (Maxillofacial Indication)FZE · Traditional | Nobel Biocare AB | 06/02/2009SE |
| K071018 | Monarch Nasal ImplantFZE · Traditional | Hanson Medical, Inc. | 05/25/2007SE |
| K041690 | Monarch Nasal ImplantFZE · Traditional | Hanson Medical, Inc. | 02/11/2005SE |
| K021418 | Aart Nasal ImplantFZE · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 07/02/2002SE |
| K992242 | Pillar Nasal, Dorsal Columella and Nasal Dorsum ImplantsFZE · Traditional | Pillar Surgical, Inc. | 11/22/1999SE |
| K983755 | Nasal Dorsal SeriesFZE · Special | Surgical Technology Laboratories, Inc. | 11/20/1998SE |
| K982753 | Seare Biomedical Nasal ImplantsFZE · Traditional | Seare Biomedical Corp. | 09/30/1998SE |
| K981833 | Silimed Nasal L Shaped ImplantFZE · Traditional | Silimed, LLC | 06/26/1998SE |
| K973573 | Duralastic Anatomical Nasal ImplantsFZE · Traditional | Hanson Medical, Inc. | 11/13/1997SE |
| K971481 | Duralastic Anatomical Nasal ImplantsFZE · Traditional | Allied Biomedical Corp. | 07/18/1997SE |
| K962824 | Implantech Jej Peri-Pyriform ImplantFZE · Traditional | Implantech Associates, Inc. | 10/03/1996SE |
| K961124 | The NautilusFZE · Traditional | Rand Scientific Corp. | 04/19/1996SE |
| K952709 | Prothesis, Chin, InternalFZE · Traditional | Spirit Ridge Technologies | 08/28/1995SE |
| K952708 | Pectoralis ImplantFZE · Traditional | Spirit Ridge Technologies | 08/28/1995SE |
| K952707 | Silicone Elastomer Malar ImplantFZE · Traditional | Spirit Ridge Technologies | 08/28/1995SE |
| K952706 | Spirit Ridge Silicone Carving BlockFZE · Traditional | Spirit Ridge Technologies | 08/28/1995SE |
| K952705 | Spirit Ridge Nasal ImplantFZE · Traditional | Spirit Ridge Technologies | 08/28/1995SE |
| K945154 | Ba-CpasFZE · Traditional | Nobelpharma USA, Inc. | 01/13/1995SE |
| K941960 | Implantech Dorsal Columella Implant Style IIFZE · Traditional | Implantech Associates, Inc. | 08/17/1994SE |
| K942876 | Implantech Dorsal Nasal ImplantFZE · Traditional | Implantech Associates, Inc. | 07/18/1994SE |
| K925743 | Nasal DorsumFZE · Traditional | Smith & Nephew Richards, Inc. | 08/10/1993SE |
| K925426 | Rizzo Nasal ImplantFZE · Traditional | Implantech Associates, Inc. | 05/12/1993SE |
| K921580 | Brink Pre-Maxillary ImplantFZE · Traditional | Implantech Associates, Inc. | 05/06/1992SE |
| K904657 | Flowers Dorsal Columella ImplantFZE · Traditional | Implantech Associates, Inc. | 12/18/1990SE |
| K904656 | Flowers Nasal ImplantFZE · Traditional | Implantech Associates, Inc. | 12/18/1990SE |
| K904350 | Cui Dorsal Columella ProsthesisFZE · Traditional | Cui Corp. | 11/26/1990SE |
| K903328 | Cui Premaxillary ImplantFZE · Traditional | Cui Corp. | 09/10/1990SE |
| K902283 | The Nautilus Nasal ImplantFZE · Traditional | Applied Biomaterial Technologies | 08/14/1990SE |
| K880405 | Silastic Nasal Implant S-TypeFZE · Traditional | Dow Corning Wright | 02/18/1988SE |
| K871071 | Omega Dorsal Columella ImplantsFZE · Traditional | Omega Silicone, Inc. | 04/13/1987SE |
| K863942 | Porex(Tm) Nose ProsthesisFZE · Traditional | Porex Medical | 10/24/1986SE |
| K863430 | Byron Bivalve Nasal SplintsFZE · Traditional | Byron Medical | 09/17/1986SE |
| K863399 | Byron Dorsal Columella ImplantFZE · Traditional | Byron Medical | 09/17/1986SE |
| K863398 | Byron Nasal Septal ButtonFZE · Traditional | Byron Medical | 09/17/1986SE |
| K853945 | Cui Rhinoplasty ImplantsFZE · Traditional | Cox-Uphuff Intl. | 10/18/1985SE |
| K822130 | Francis Nasal TubeFZE · Traditional | Tekna Med Corp. | 10/13/1982SE |
| K801074 | Straith Nasal ImplantFZE · Traditional | Surgical Technology Laboratories, Inc. | 06/17/1980SE |
| K782104 | Paste, Pro Care ProphylaxisFZE · Traditional | Young Dental Manufacturing Co. 1, LLC | 01/03/1979SE |
| K781574 | Plasti-Pore Septal ButtonFZE · Traditional | Richard'S Medical Equip., Inc. | 09/27/1978SE |