FDA 510(k) Applications for Medical Device Product Code "FWP"
(Prosthesis, Chin, Internal)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K021417 | AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. | AART CHIN IMPLANT | 07/02/2002 |
| K971478 | ALLIED BIOMEDICAL CORP. | DURALASTIC ANATOMICAL CHIN IMPLANTS | 07/18/1997 |
| K960349 | CERAMED CORP. | PERMARIDGE HYDROXYLAPATITE MATRIX | 03/13/1996 |
| K973575 | HANSON MEDICAL, INC. | DURALASTIC ANATOMICAL CHIN IMPLANTS | 11/07/1997 |
| K121315 | HOWMEDICA OSTEONICS CORP. | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | 11/01/2012 |
| K141027 | IMPLANTECH ASSOCIATES INC. | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP | 07/10/2014 |
| K191130 | Implantech Associates Inc. | Customized Contour Implant | 08/23/2019 |
| K200610 | Implantech Associates Inc. | Customized Contour Implant | 12/23/2020 |
| K992239 | PILLAR SURGICAL, INC. | PILLAR CHIN IMPLANT | 11/22/1999 |
| K012350 | POREX SURGICAL, INC. | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL | 03/14/2002 |
| K152463 | PORIFEROUS LLC | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant | 01/20/2016 |
| K961071 | RAND SCIENTIFIC CORP. | THE MAGNUM CHIN IMPLANT | 04/19/1996 |
| K982752 | SEARE BIOMEDICAL CORP. | SEARE BIOMEDICAL CHIN IMPLANTS | 09/30/1998 |
| K981850 | SILIMED, LLC. | SILIMED CHIN IMPLANTS | 07/09/1998 |
| K980462 | SPECTRUM DESIGNS, INC. | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT | 05/06/1998 |
| K980446 | SPECTRUM DESIGNS, INC. | SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT | 05/06/1998 |
| K980444 | SPECTRUM DESIGNS, INC. | SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT | 05/06/1998 |
| K980461 | SPECTRUM DESIGNS, INC. | SPECTRUM DESIGNS CLEFT CHIN IMPLANT | 03/04/1998 |
| K980445 | SPECTRUM DESIGNS, INC. | SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT | 05/06/1998 |
| K980463 | SPECTRUM DESIGNS, INC. | SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT | 05/06/1998 |
| K980138 | SPECTRUM DESIGNS, INC. | SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT | 04/03/1998 |
| K143173 | Stryker | Stryker CMF MEDPOR Customized Implant | 03/23/2015 |
| K153508 | Stryker | Stryker CMF MEDPOR Customized Implant | 02/05/2016 |
| K191916 | Stryker Leibinger GmbH & Co. KG | Stryker CMF MEDPOR Priority Customized Implant Kit | 08/15/2019 |
| K091011 | SURGICAL TECHNOLOGY LABORATORIES, INC ("STL") | PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) | 04/22/2009 |
| K983754 | SURGICAL TECHNOLOGY LABORATORIES, INC. | STANDARD CHIN | 11/20/1998 |
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