FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K153613 |
ACERA SURGICAL, INC. |
Cerafix Dura Substitute |
03/16/2016 |
K161278 |
ACERA SURGICAL, INC. |
Cerafix Dura Substitute |
08/08/2016 |
K172603 |
Acera Surgical, Inc. |
Cerafix Dura Substitute |
11/27/2017 |
K970851 |
AESCULAP, INC. |
LYOPLANT DURA SUBSTITUTE(VARIOUS) |
12/09/1997 |
K122791 |
AESCULAP, INC. |
LYOPLANT ONLAY |
06/04/2013 |
K960470 |
AESCULAP, INC. |
NEURO-PATCH |
05/10/1996 |
K982282 |
BIO-VASCULAR, INC. |
DURA-GUARD - DURAL REPAIR PATCH |
07/30/1998 |
K973706 |
BIO-VASCULAR, INC. |
DURA-GUARD-DURAL REPAIR PATCH |
12/24/1997 |
K980548 |
BRIDGER BIOMED, INC. |
DURA-PATCH MODEL DP-XXX |
05/13/1998 |
K041518 |
Codman & Shurtleff, Inc. |
CODMAN DURAFORM DURAL GRAFT IMPLANT |
06/22/2004 |
K152481 |
CODMAN & SHURTLEFF, INC. |
DURAFORM Dural Graft Implant |
10/30/2015 |
K141608 |
COLLAGEN MATRIX, INC. |
COLLAGEN DURA MEMBRANE |
01/16/2015 |
K150825 |
COLLAGEN MATRIX, INC. |
Collagen Dural Regeneration Matrix |
11/20/2015 |
K040888 |
COLLAGEN MATRIX, INC. |
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE |
12/01/2004 |
K061487 |
COLLAGEN MATRIX, INC. |
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE |
06/26/2006 |
K131015 |
COOK BIOTECH, INC. |
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT |
10/08/2013 |
K031850 |
COOK BIOTECH, INC. |
DURASIS DURAL SUBSTITUTE |
09/08/2003 |
K120600 |
INTEGRA LIFESCIENCES |
DURAGEN SECURE DURAL REGNERATION MATRIX |
06/15/2012 |
K982180 |
INTEGRA LIFESCIENCES CORP. |
DURAGEN DURAL GRAFT MATRIX |
07/06/1999 |
K043427 |
INTEGRA LIFESCIENCES CORP. |
DURAGEN II DURAL REGENERATION MATRIX |
01/12/2005 |
K032693 |
INTEGRA LIFESCIENCES CORP. |
DURAGEN PLUS DURAL GRAFT MATRIX |
09/30/2003 |
K072207 |
INTEGRA LIFESCIENCES CORP. |
DURAGEN XS DURAL REGENERATION MATRIX |
08/23/2007 |
K092388 |
INTEGRA LIFESCIENCES CORPORATION |
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO |
01/21/2010 |
K163456 |
INTEGRA LIFESCIENCES CORPORATION |
DuraGen Secure Dural Regeneration Matrix |
01/06/2017 |
K991413 |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
CODMAN ETHISORB DURA PATCH |
03/13/2000 |
K183513 |
LeMaitre Vascular Inc. |
XenoSure Dura Biologic Patch |
06/13/2019 |
K061208 |
LIFECELL CORP. |
LIFECELL DURAL SUBSTITUTE MATRIX |
01/03/2007 |
K052211 |
MEDTRONIC NEUROSURGERY |
DUREPAIR DURA REGENERATION MATRIX |
09/14/2005 |
K041000 |
MEDTRONIC NEUROSURGERY |
DUREPAIR DURA REGENERATION MATRIX |
07/27/2004 |
K161370 |
Medtronic Neurosurgery |
Durepair Dura Regeneration Matrix |
11/02/2016 |
K063117 |
MEDTRONIC NEUROSURGERY |
MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX |
11/03/2006 |
K223445 |
Nurami Medical Ltd. |
ArtiFascia |
08/10/2023 |
K132850 |
RTI SURGICAL, INC. |
BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM |
03/31/2014 |
K982101 |
SHELHIGH, INC. |
SHELHIGH NO-REACT DURA SHIELD |
05/02/2000 |
K113071 |
SYNTHES |
SYNTHECEL DURA REPLACEMENT DEVICES |
01/09/2012 |
K212943 |
Synthes (USA) products, LLC |
SyntheCel Dura Repair |
01/28/2022 |
K131792 |
SYNTHES INC |
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY |
12/16/2013 |
K021477 |
W. L. GORE & ASSOCIATES, INC. |
PRECLUDE MVP DURA SUBSTITUTE |
11/08/2002 |
K984534 |
W.L. GORE & ASSOCIATES,INC |
PRECLUDE ACUSEAL DURA SUBSTITUTE |
03/15/1999 |