FWP — Prosthesis, Chin, Internal Class II
FDA product code FWP covers "Prosthesis, Chin, Internal", a Class II medical device regulated under 21 CFR 878.3550. 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
- FWP
- Device Class
- Class II
- Regulation Number
- 878.3550
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254233 | stryker leibinger gmbh and co kg | MEDPOR Customized Implant Kit | March 12, 2026 |
| K232593 | keosan trading | FITme Customized Silicone Implant | November 22, 2023 |
| K200610 | implantech associates | Customized Contour Implant | December 23, 2020 |
| K191130 | implantech associates | Customized Contour Implant | August 23, 2019 |
| K191916 | stryker leibinger gmbh and co kg | Stryker CMF MEDPOR Priority Customized Implant Kit | August 15, 2019 |
| K153508 | stryker | Stryker CMF MEDPOR Customized Implant | February 5, 2016 |
| K152463 | poriferous | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant | January 20, 2016 |
| K143173 | stryker | Stryker CMF MEDPOR Customized Implant | March 23, 2015 |
| K141027 | implantech associates | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, S | July 10, 2014 |
| K121315 | howmedica osteonics | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | November 1, 2012 |
| K091011 | surgical technology laboratories, inc ("stl") | PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) | April 22, 2009 |
| K021417 | aesthetic and reconstructive technologies | AART CHIN IMPLANT | July 2, 2002 |
| K012350 | porex surgical | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL | March 14, 2002 |
| K992239 | pillar surgical | PILLAR CHIN IMPLANT | November 22, 1999 |
| K983754 | surgical technology laboratories | STANDARD CHIN | November 20, 1998 |
| K982752 | seare biomedical | SEARE BIOMEDICAL CHIN IMPLANTS | September 30, 1998 |
| K981850 | silimed | SILIMED CHIN IMPLANTS | July 9, 1998 |
| K980444 | spectrum designs | SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT | May 6, 1998 |
| K980462 | spectrum designs | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT | May 6, 1998 |
| K980445 | spectrum designs | SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT | May 6, 1998 |