Product code FZE
- Device name
- Prosthesis, Nose, Internal
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3680
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241253 | Medicon Epiplating System | Cmf Medicon Surgical, Inc. | 2024-12-12 |
| K161548 | Osseointegrated Fixtures | Southern Implants (Pty), Ltd. | 2016-12-01 |
| K090803 | HANSON MEDICAL FACIAL IMPLANTS | Hanson Medical, Inc. | 2010-06-30 |
| K090630 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) | Nobel Biocare AB | 2009-06-02 |
| K071018 | MONARCH NASAL IMPLANT | Hanson Medical, Inc. | 2007-05-25 |
| K041690 | MONARCH NASAL IMPLANT | Hanson Medical, Inc. | 2005-02-11 |
| K021418 | AART NASAL IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 |
| K992242 | PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS | Pillar Surgical, Inc. | 1999-11-22 |
| K983755 | NASAL DORSAL SERIES | Surgical Technology Laboratories, Inc. | 1998-11-20 |
| K982753 | SEARE BIOMEDICAL NASAL IMPLANTS | Seare Biomedical Corp. | 1998-09-30 |
| K981833 | SILIMED NASAL L SHAPED IMPLANT | Silimed, LLC | 1998-06-26 |
| K973573 | DURALASTIC ANATOMICAL NASAL IMPLANTS | Hanson Medical, Inc. | 1997-11-13 |
| K971481 | DURALASTIC ANATOMICAL NASAL IMPLANTS | Allied Biomedical Corp. | 1997-07-18 |
| K962824 | IMPLANTECH JEJ PERI-PYRIFORM IMPLANT | Implantech Associates, Inc. | 1996-10-03 |
| K961124 | THE NAUTILUS | Rand Scientific Corp. | 1996-04-19 |
| K952709 | PROTHESIS, CHIN, INTERNAL | Spirit Ridge Technologies | 1995-08-28 |
| K952708 | PECTORALIS IMPLANT | Spirit Ridge Technologies | 1995-08-28 |
| K952707 | SILICONE ELASTOMER MALAR IMPLANT | Spirit Ridge Technologies | 1995-08-28 |
| K952706 | SPIRIT RIDGE SILICONE CARVING BLOCK | Spirit Ridge Technologies | 1995-08-28 |
| K952705 | SPIRIT RIDGE NASAL IMPLANT | Spirit Ridge Technologies | 1995-08-28 |
| K945154 | BA-CPAS | Nobelpharma USA, Inc. | 1995-01-13 |
| K941960 | IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II | Implantech Associates, Inc. | 1994-08-17 |
| K942876 | IMPLANTECH DORSAL NASAL IMPLANT | Implantech Associates, Inc. | 1994-07-18 |
| K925743 | NASAL DORSUM | Smith & Nephew Richards, Inc. | 1993-08-10 |
| K925426 | RIZZO NASAL IMPLANT | Implantech Associates, Inc. | 1993-05-12 |
| K921580 | BRINK PRE-MAXILLARY IMPLANT | Implantech Associates, Inc. | 1992-05-06 |
| K904656 | FLOWERS NASAL IMPLANT | Implantech Associates, Inc. | 1990-12-18 |
| K904657 | FLOWERS DORSAL COLUMELLA IMPLANT | Implantech Associates, Inc. | 1990-12-18 |
| K904350 | CUI DORSAL COLUMELLA PROSTHESIS | Cui Corp. | 1990-11-26 |
| K903328 | CUI PREMAXILLARY IMPLANT | Cui Corp. | 1990-09-10 |
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|---|---|---|---|
| 09321502020732 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502021760 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502021777 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502034579 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502040075 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502040082 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502040099 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502015615 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 00841036200459 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-10-01 |
| 00841036200565 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-10-01 |
| 00841036200466 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-10-01 |
| 00841036200473 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-10-01 |
| 00841036200503 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-10-01 |
| 00841036200510 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-10-01 |
| 00841036200527 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-10-01 |
| 00841036200534 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-10-01 |
| 00841036200541 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-10-01 |
| 00841036200558 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-10-01 |
| 00841036200435 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-09-30 |
| 00841036200428 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-09-30 |
| 00841036200411 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-09-30 |
| 00841036200480 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-09-30 |
| 00841036200374 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-09-29 |
| 00841036200350 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-09-29 |
| 00841036200343 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-09-29 |
| 00841036200336 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-09-29 |
| 00841036200329 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-09-29 |
| 00841036200312 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-09-29 |
| 00841036200305 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-09-29 |
| 00841036199357 | HTR-PMI | BIOMET MICROFIXATION, INC | 2015-09-24 |