FZE — Prosthesis, Nose, Internal Class II
FDA product code FZE covers "Prosthesis, Nose, Internal", a Class II medical device regulated under 21 CFR 878.3680. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FZE
- Device Class
- Class II
- Regulation Number
- 878.3680
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241253 | cmf medicon surgical | Medicon Epiplating System | December 12, 2024 |
| K161548 | southern implants (pty) | Osseointegrated Fixtures | December 1, 2016 |
| K090803 | hanson medical | HANSON MEDICAL FACIAL IMPLANTS | June 30, 2010 |
| K090630 | nobel biocare | NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) | June 2, 2009 |
| K071018 | hanson medical | MONARCH NASAL IMPLANT | May 25, 2007 |
| K041690 | hanson medical | MONARCH NASAL IMPLANT | February 11, 2005 |
| K021418 | aesthetic and reconstructive technologies | AART NASAL IMPLANT | July 2, 2002 |
| K992242 | pillar surgical | PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS | November 22, 1999 |
| K983755 | surgical technology laboratories | NASAL DORSAL SERIES | November 20, 1998 |
| K982753 | seare biomedical | SEARE BIOMEDICAL NASAL IMPLANTS | September 30, 1998 |
| K981833 | silimed | SILIMED NASAL L SHAPED IMPLANT | June 26, 1998 |
| K973573 | hanson medical | DURALASTIC ANATOMICAL NASAL IMPLANTS | November 13, 1997 |
| K971481 | allied biomedical | DURALASTIC ANATOMICAL NASAL IMPLANTS | July 18, 1997 |
| K962824 | implantech associates | IMPLANTECH JEJ PERI-PYRIFORM IMPLANT | October 3, 1996 |
| K961124 | rand scientific | THE NAUTILUS | April 19, 1996 |
| K952706 | spirit ridge technologies | SPIRIT RIDGE SILICONE CARVING BLOCK | August 28, 1995 |
| K952709 | spirit ridge technologies | PROTHESIS, CHIN, INTERNAL | August 28, 1995 |
| K952707 | spirit ridge technologies | SILICONE ELASTOMER MALAR IMPLANT | August 28, 1995 |
| K952708 | spirit ridge technologies | PECTORALIS IMPLANT | August 28, 1995 |
| K952705 | spirit ridge technologies | SPIRIT RIDGE NASAL IMPLANT | August 28, 1995 |