KKY · Class II · 21 CFR 878.3500

FDA Product Code KKY: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Leading manufacturers include Ceremed , Inc., Matrix Surgical USA and Matrix Surgical Holdings, LLC/Matrix Surgical USA.

25
Total
25
Cleared
164d
Avg days
1978
Since

FDA 510(k) Cleared Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction Devices (Product Code KKY)

25 devices
1–24 of 25
Cleared Jul 15, 2021
Longeviti PorousFit implant
K211514
Longeviti Neuro Solutions, LLC
General & Plastic Surgery · 59d
Cleared Jul 20, 2016
OsteoFab Patient Specific Facial Device
K161052
Oxford Performance Materials, Inc.
General & Plastic Surgery · 97d
Cleared Jul 14, 2016
Biopor, AOC Porous Polyethylene, Cerepor
K160988
Ceremed , Inc.
General & Plastic Surgery · 97d
Cleared Apr 16, 2015
BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
K141880
Ceremed , Inc.
General & Plastic Surgery · 279d
Cleared Jul 28, 2014
OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
K133809
Oxford Performance Materials
General & Plastic Surgery · 224d
Cleared Jun 13, 2014
SU-POR SURGICAL IMPLANT
K140437
Poriferous, LLC
General & Plastic Surgery · 112d
Cleared May 14, 2014
OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
K133046
Matrix Surgical Holdings, LLC/Matrix Surgical USA
General & Plastic Surgery · 229d
Cleared Jul 31, 2013
OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
K123908
Matrix Surgical USA
General & Plastic Surgery · 224d
Cleared Nov 16, 2011
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
K111323
Synthes, Inc.
General & Plastic Surgery · 189d
Cleared Oct 26, 2010
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
K103010
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
General & Plastic Surgery · 14d
Cleared Apr 21, 2008
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT
K080507
Ceremed , Inc.
General & Plastic Surgery · 56d
Cleared Oct 19, 2007
BONALIVE GRANULES AND BONALIVE PLATES
K071937
Vivoxid , Ltd.
General & Plastic Surgery · 98d
Cleared Apr 15, 2005
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
K043250
Stryker Leibinger
General & Plastic Surgery · 143d
Cleared Mar 02, 2005
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR
K043133
Ceremed , Inc.
General & Plastic Surgery · 110d
Cleared Oct 16, 2002
SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
K021889
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 131d
Cleared Oct 09, 2002
POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
K022665
Hohenstein Enterprises, Inc.
General & Plastic Surgery · 61d
Cleared May 16, 2002
IMMIX BONE GRAFT EXTENDER
K013764
Osteogenics Biomedical, Inc.
General & Plastic Surgery · 184d
Cleared Aug 18, 1995
TLC SURGICAL DRAPES
K951474
Tlc Tech Lab Clothes, Inc.
General & Plastic Surgery · 141d
Cleared Nov 04, 1994
HARD TISSUE REPLACEMENT (HTR) GRANULAR
K934861
Poly-Medics,Inc.
General & Plastic Surgery · 388d
Cleared Sep 30, 1994
SURGICAL APPAREL
K935199
Associated Hospital Services, Inc.
General Hospital · 338d
Cleared Sep 02, 1993
HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
K924935
Polyclinic Medical Center
General & Plastic Surgery · 337d
Cleared Feb 03, 1992
MAALEABLE FACIAL IMPLANT
K915445
Biomet Ussc Orthopedics
General & Plastic Surgery · 60d
Cleared Nov 23, 1990
HTR POLYMER, HTR-MX
K904111
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 78d
Cleared Mar 08, 1990
UHMWPE SURGICAL MESH
K894478
Biomet, Inc.
General & Plastic Surgery · 233d

About Product Code KKY - Regulatory Context