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 |