FDA 510(k) Applications for Medical Device Product Code "GXQ"
(Dura Substitute)
| 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 |
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