FWPClass II
Prosthesis, Chin, Internal
21 CFR 878.3550 / General, Plastic Surgery
FWP is the FDA product code for Prosthesis, Chin, Internal, a class II device type, regulated under 21 CFR 878.3550. As of , FDA records hold 66 510(k) clearances under this code, the most recent dated , and 5 recalls.
Classification record
- Product code
- FWP
- Device name
- Prosthesis, Chin, Internal
- Regulation
- 21 CFR 878.3550
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 66
- Ingested recalls
- 5
Clearances, product code FWP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1980 | 1 |
| 1981 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1986 | 2 |
| 1987 | 3 |
| 1990 | 8 |
| 1991 | 9 |
| 1992 | 2 |
| 1994 | 5 |
| 1995 | 3 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 10 |
| 1999 | 1 |
| 2002 | 2 |
| 2009 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2023 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code FWP| Applicant | Clearances |
|---|---|
| Implantech Associates Inc | 16 |
| Spectrum Designs, Inc. | 7 |
| Byron Medical | 4 |
| W. L. Gore & Associates, Inc. | 3 |
| Applied Biomaterial Technologies | 2 |
| Cui Corp. | 2 |
| Omega Silicone, Inc. | 2 |
| Porex Medical | 2 |
| Porex Surgical, Inc. | 2 |
| Stryker Corp. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
