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 |