FDA Product Code
FDA Product Code FWP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3550
510(k) Clearances — 66 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254233 | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2026-03-12 | Special | PDF ↗ |
| K232593 | FITme Customized Silicone Implant | Keosan Trading Co. | 2023-11-22 | Traditional | PDF ↗ |
| K200610 | Customized Contour Implant | Implantech Associates, Inc. | 2020-12-23 | Traditional | PDF ↗ |
| K191130 | Customized Contour Implant | Implantech Associates, Inc. | 2019-08-23 | Traditional | PDF ↗ |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2019-08-15 | Special | PDF ↗ |
| K153508 | Stryker CMF MEDPOR Customized Implant | Stryker | 2016-02-05 | Traditional | PDF ↗ |
| K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant | Poriferous, LLC | 2016-01-20 | Traditional | PDF ↗ |
| K143173 | Stryker CMF MEDPOR Customized Implant | Stryker | 2015-03-23 | Traditional | PDF ↗ |
| K141027 | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP | Implantech Associates, Inc. | 2014-07-10 | Traditional | PDF ↗ |
| K121315 | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | Howmedica Osteonics Corp. | 2012-11-01 | Traditional | PDF ↗ |
| K091011 | PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) | Surgical Technology Laboratories, Inc ("Stl") | 2009-04-22 | Traditional | PDF ↗ |
| K021417 | AART CHIN IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 | Traditional | PDF ↗ |
| K012350 | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL | Porex Surgical, Inc. | 2002-03-14 | Traditional | PDF ↗ |
| K992239 | PILLAR CHIN IMPLANT | Pillar Surgical, Inc. | 1999-11-22 | Traditional | PDF ↗ |
| K983754 | STANDARD CHIN | Surgical Technology Laboratories, Inc. | 1998-11-20 | Special | PDF ↗ |
| K982752 | SEARE BIOMEDICAL CHIN IMPLANTS | Seare Biomedical Corp. | 1998-09-30 | Traditional | PDF ↗ |
| K981850 | SILIMED CHIN IMPLANTS | Silimed, LLC | 1998-07-09 | Traditional | PDF ↗ |
| K980444 | SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 | Traditional | PDF ↗ |
| K980463 | SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 | Traditional | PDF ↗ |
| K980462 | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 | Traditional | PDF ↗ |
| K980446 | SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 | Traditional | PDF ↗ |
| K980445 | SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 | Traditional | PDF ↗ |
| K980138 | SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT | Spectrum Designs, Inc. | 1998-04-03 | Traditional | PDF ↗ |
| K980461 | SPECTRUM DESIGNS CLEFT CHIN IMPLANT | Spectrum Designs, Inc. | 1998-03-04 | Traditional | PDF ↗ |
| K973575 | DURALASTIC ANATOMICAL CHIN IMPLANTS | Hanson Medical, Inc. | 1997-11-07 | Traditional | PDF ↗ |
| K971478 | DURALASTIC ANATOMICAL CHIN IMPLANTS | Allied Biomedical Corp. | 1997-07-18 | Traditional | PDF ↗ |
| K961071 | THE MAGNUM CHIN IMPLANT | Rand Scientific Corp. | 1996-04-19 | Traditional | PDF ↗ |
| K960349 | PERMARIDGE HYDROXYLAPATITE MATRIX | Ceramed Corp. | 1996-03-13 | Traditional | PDF ↗ |
| K952677 | MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL | Porex Surgical, Inc. | 1995-08-21 | Traditional | PDF ↗ |
| K946267 | GORE-TEX SAM FACIAL IMPLANT | W. L. Gore & Associates, Inc. | 1995-03-22 | Traditional | PDF ↗ |
| K945998 | CHIN IMPLANT STYLE I | King & Spalding | 1995-02-07 | Traditional | PDF ↗ |
| K925610 | FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN | Microtek Medical, Inc. | 1994-11-18 | Traditional | PDF ↗ |
| K931500 | THE PERMARIDGE MATRIX CHIN | Applied Biomaterial Technologies | 1994-11-17 | Traditional | PDF ↗ |
| K943644 | IMPLANTECH TEMPORAL IMPLANT | Implantech Associates, Inc. | 1994-10-18 | Traditional | PDF ↗ |
| K933367 | GORE-TEX FACIAL IMPLANT | W. L. Gore & Associates, Inc. | 1994-07-28 | Traditional | PDF ↗ |
| K942280 | GORETEX SAM FACIAL IMPLANT | W. L. Gore & Associates, Inc. | 1994-07-28 | Traditional | PDF ↗ |
| K922489 | MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA | Porex Technologies Corp. | 1992-09-02 | Traditional | PDF ↗ |
| K921581 | CHIN WAFER | Implantech Associates, Inc. | 1992-05-06 | Traditional | PDF ↗ |
| K914297 | K.D. CHIN IMPLANT | Implantech Associates, Inc. | 1991-12-19 | Traditional | PDF ↗ |
| K913761 | 3-D ACCUSCAN FACIAL IMPLANTS | Implantech Associates, Inc. | 1991-10-17 | Traditional | PDF ↗ |
| K911516 | HIGH PROFILE CHIN IMPLANT | Implantech Associates, Inc. | 1991-07-01 | Traditional | PDF ↗ |
| K911514 | ARTICULATED CHIN IMPLANT | Implantech Associates, Inc. | 1991-07-01 | Traditional | PDF ↗ |
| K910456 | ZARA CHIN IMPLANT | Byron Medical | 1991-02-19 | Traditional | PDF ↗ |
| K910458 | ZARA SOFT TIP CHIN IMPLANT | Byron Medical | 1991-02-19 | Traditional | PDF ↗ |
| K910457 | ZARA EXTENDED CHIN IMPLANT | Byron Medical | 1991-02-19 | Traditional | PDF ↗ |
| K905267 | FLOWERS CHIN IMPLANT | Implantech Associates, Inc. | 1991-01-31 | Traditional | PDF ↗ |
| K905268 | FLOWERS JOWL IMPLANT | Implantech Associates, Inc. | 1991-01-31 | Traditional | PDF ↗ |
| K904349 | CUI CURVILINEAR SILICONE CHIN | Cui Corp. | 1990-11-26 | Traditional | PDF ↗ |
| K902285 | THE MAGNUM CHIN IMPLANT | Applied Biomaterial Technologies | 1990-09-12 | Traditional | PDF ↗ |
| K903327 | CUI ARTICULATED SILICONE CHIN | Cui Corp. | 1990-09-10 | Traditional | PDF ↗ |
| K902941 | CURVILINEAR SILICONE CHIN IMPLANT | Implantech Associates, Inc. | 1990-08-02 | Traditional | PDF ↗ |
| K902824 | EXTENDED CHIN IMPLANT STYLE I | Implantech Associates, Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K902826 | ANATOMICAL MANDIBULAR IMPLANT STYLE I | Implantech Associates, Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K902825 | EXTENDED CHIN IMPLANT STYLE II | Implantech Associates, Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K902827 | ANATOMICAL MANDIBULAR IMPLANT STYLE II | Implantech Associates, Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K871070 | OMEGA SILICONE CHIN IMPLANT | Omega Silicone, Inc. | 1987-05-11 | Traditional | PDF ↗ |
| K871190 | ANADIAS ZARA SYSTEM MALAR IMPLANTS | Anadias, Inc. | 1987-04-10 | Traditional | PDF ↗ |
| K871074 | OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR | Omega Silicone, Inc. | 1987-04-10 | Traditional | PDF ↗ |
| K863941 | POREX(TM) PROSTHESIS, CHIN, INTERNAL | Porex Medical | 1986-10-24 | Traditional | PDF ↗ |
| K863397 | BYRON SILICONE CHIN IMPLANTS | Byron Medical | 1986-09-18 | Traditional | PDF ↗ |
| K832283 | MEDPAR SURGICAL IMPLANTS | Porex Medical | 1984-05-10 | Traditional | PDF ↗ |
| K832148 | PDM SILOXANE PROSTHETIC CHIN IMPLANT | Delaware Prosthetics, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K831724 | CHIN (MENTOPLASTY) IMPLANTS | S. Jackson, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K812210 | CREAT BRAND WAGNER CHIN IMPLANT | Aesthetech Corp. | 1981-09-11 | Traditional | PDF ↗ |
| K801073 | STRAITH CHIN IMPLANTS | Surgical Technology Laboratories, Inc. | 1980-05-20 | Traditional | PDF ↗ |
| K760562 | CHIN IMPLANTS | Mediplast Laboratories, Inc. | 1976-11-02 | Traditional | PDF ↗ |
Product code FWP · Class II · General, Plastic Surgery. Data: openFDA.