FDA 510(k) Applications for Medical Device Product Code "KKY"
(Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction)

FDA 510(k) Number Applicant Device Name Decision Date
K080507 CEREMED, INC. AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT 04/21/2008
K043133 CEREMED, INC. AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR 03/02/2005
K141880 CEREMED, INC. BIOPOR AOC POROUS POLYETHYLENE, CEREPOR 04/16/2015
K160988 CEREMED, INC. Biopor, AOC Porous Polyethylene, Cerepor 07/14/2016
K022665 HOHENSTEIN ENTERPRISES, INC. POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE 10/09/2002
K103010 HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS STRYKER PATIENT SPECIFIC POLYMER IMPLANT 10/26/2010
K211514 Longeviti Neuro Solutions, LLC Longeviti PorousFit implant 07/15/2021
K133046 MATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA OMNIPORE CUSTOMIZED SURGICAL IMPLANTS 05/14/2014
K123908 MATRIX SURGICAL USA OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES 07/31/2013
K013764 OSTEOGENICS BIOMEDICAL, INC. IMMIX BONE GRAFT EXTENDER 05/16/2002
K133809 OXFORD PERFORMANCE MATERIALS OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE 07/28/2014
K161052 OXFORD PERFORMANCE MATERIALS, INC. OsteoFab Patient Specific Facial Device 07/20/2016
K140437 PORIFEROUS, LLC. SU-POR SURGICAL IMPLANT 06/13/2014
K043250 STRYKER LEIBINGER STRYKER PATIENT SPECIFIC POLYMER IMPLANT 04/15/2005
K021889 SURGICAL TECHNOLOGY LABORATORIES, INC. SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) 10/16/2002
K111323 SYNTHES INC SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS 11/16/2011
K071937 VIVOXID LTD. BONALIVE GRANULES AND BONALIVE PLATES 10/19/2007


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