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 Holdings, LLC/Matrix Surgical USA and Oxford Performance Materials.

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 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 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
Cleared Aug 14, 1978
SURG. GOWN & DRAPE, LOW LINT TREATMENT
K781019
Kimberly-Clark Corp.
General & Plastic Surgery · 210d

About Product Code KKY - Regulatory Context