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KKY — Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction Class II

FDA Device Classification

Classification Details

Product Code
KKY
Device Class
Class II
Regulation Number
878.3500
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K211514longeviti neuro solutionsLongeviti PorousFit implantJuly 15, 2021
K161052oxford performance materialsOsteoFab Patient Specific Facial DeviceJuly 20, 2016
K160988ceremedBiopor, AOC Porous Polyethylene, CereporJuly 14, 2016
K141880ceremedBIOPOR AOC POROUS POLYETHYLENE, CEREPORApril 16, 2015
K133809oxford performance materialsOSTEOFAB PATIENT SPECIFIC FACIAL DEVICEJuly 28, 2014
K140437poriferousSU-POR SURGICAL IMPLANTJune 13, 2014
K133046matrix surgical holdings, llc/matrix surgical usaOMNIPORE CUSTOMIZED SURGICAL IMPLANTSMay 14, 2014
K123908matrix surgical usaOMNIPORE SURGICAL IMPLANTS AND ACCESSORIESJuly 31, 2013
K111323synthesSYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTSNovember 16, 2011
K103010howmedica osteonics corp., dba stryker orthopaedicsSTRYKER PATIENT SPECIFIC POLYMER IMPLANTOctober 26, 2010
K080507ceremedAOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLAApril 21, 2008
K071937vivoxidBONALIVE GRANULES AND BONALIVE PLATESOctober 19, 2007
K043250stryker leibingerSTRYKER PATIENT SPECIFIC POLYMER IMPLANTApril 15, 2005
K043133ceremedAOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLAMarch 2, 2005
K021889surgical technology laboratoriesSURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)October 16, 2002
K022665hohenstein enterprisesPOROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDOctober 9, 2002
K013764osteogenics biomedicalIMMIX BONE GRAFT EXTENDERMay 16, 2002
K951474tlc tech lab clothesTLC SURGICAL DRAPESAugust 18, 1995
K934861poly-medicsHARD TISSUE REPLACEMENT (HTR) GRANULARNovember 4, 1994
K935199associated hospital servicesSURGICAL APPARELSeptember 30, 1994