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FWP — Prosthesis, Chin, Internal Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K254233stryker leibinger gmbh and co kgMEDPOR Customized Implant KitMarch 12, 2026
K232593keosan tradingFITme Customized Silicone ImplantNovember 22, 2023
K200610implantech associatesCustomized Contour ImplantDecember 23, 2020
K191130implantech associatesCustomized Contour ImplantAugust 23, 2019
K191916stryker leibinger gmbh and co kgStryker CMF MEDPOR Priority Customized Implant KitAugust 15, 2019
K153508strykerStryker CMF MEDPOR Customized ImplantFebruary 5, 2016
K152463poriferousSU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantJanuary 20, 2016
K143173strykerStryker CMF MEDPOR Customized ImplantMarch 23, 2015
K141027implantech associates3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SJuly 10, 2014
K121315howmedica osteonicsSTRYKER CMF MEDPOR CUSTOMIZED IMPLANTNovember 1, 2012
K091011surgical technology laboratories, inc ("stl")PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)April 22, 2009
K021417aesthetic and reconstructive technologiesAART CHIN IMPLANTJuly 2, 2002
K012350porex surgicalMEDPOR PLUS SURGICAL IMPLANT BIOMATERIALMarch 14, 2002
K992239pillar surgicalPILLAR CHIN IMPLANTNovember 22, 1999
K983754surgical technology laboratoriesSTANDARD CHINNovember 20, 1998
K982752seare biomedicalSEARE BIOMEDICAL CHIN IMPLANTSSeptember 30, 1998
K981850silimedSILIMED CHIN IMPLANTSJuly 9, 1998
K980462spectrum designsSPECTRUM DESIGNS ANATOMICAL CHIN IMPLANTMay 6, 1998
K980463spectrum designsSPECTRUM DESIGNS CURVILINEAR CHIN IMPLANTMay 6, 1998
K980444spectrum designsSPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANTMay 6, 1998