Dura Substitute
Regulation 882.5910
1510(k)s in 12 months (43 all time)
0recalls in 12 months (23 all time)
20recalls that name a 510(k)
Top companies in GXQ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 18, 2025 | K251191 | Collagen Dura Regeneration Membrane - Repair Collagen Matrix, Inc. | GXQ |
| May 14, 2025 | K250420 | Helios Dura Regeneration Matrix Helios Biomedical, Inc. | GXQ |
| Aug 10, 2023 | K223445 | ArtiFascia Nurami Medical , Ltd., IL | GXQ |
| Jan 28, 2022 | K212943 | SyntheCel Dura Repair Synthes (USA) Products, LLC | GXQ |
| Jun 13, 2019 | K183513 | XenoSure Dura Biologic Patch LeMaitre Vascular, Inc. | GXQ |
| Nov 27, 2017 | K172603 | Cerafix Dura Substitute Acera Surgical, Inc. | GXQ |
| Jan 6, 2017 | K163456 | DuraGen Secure Dural Regeneration Matrix Integra LifeSciences Corporation | GXQ |
| Nov 2, 2016 | K161370 | Durepair Dura Regeneration Matrix Medtronic Neurosurgery | GXQ |
| Aug 8, 2016 | K161278 | Cerafix Dura Substitute Acera Surgical, Inc. | GXQ |
| Mar 16, 2016 | K153613 | Cerafix Dura Substitute Acera Surgical, Inc. | GXQ |
| Nov 20, 2015 | K150825 | Collagen Dural Regeneration Matrix Collagen Matrix, Inc. | GXQ |
| Oct 30, 2015 | K152481 | DURAFORM Dural Graft Implant Codman & Shurtleff, Inc. | GXQ |
| Jan 16, 2015 | K141608 | COLLAGEN DURA MEMBRANE Collagen Matrix, Inc. | GXQ |
| Mar 31, 2014 | K132850 | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM Rti Surgical, Inc. | GXQ |
| Dec 16, 2013 | K131792 | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY Synthes, Inc. | GXQ |
| Oct 8, 2013 | K131015 | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT Cook Biotech, Inc. | GXQ |
| Jun 4, 2013 | K122791 | LYOPLANT ONLAY Aesculap, Inc. | GXQ |
| Jun 15, 2012 | K120600 | DURAGEN SECURE DURAL REGNERATION MATRIX Integra Life Sciences | GXQ |
| Jan 9, 2012 | K113071 | SYNTHECEL DURA REPLACEMENT DEVICES Synthes | GXQ |
| Jan 21, 2010 | K092388 | DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO Integra LifeSciences Corporation | GXQ |
| Aug 23, 2007 | K072207 | DURAGEN XS DURAL REGENERATION MATRIX Integra Lifesciences Corp. | GXQ |
| Jan 3, 2007 | K061208 | LIFECELL DURAL SUBSTITUTE MATRIX Lifecell Corp. | GXQ |
| Nov 3, 2006 | K063117 | MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX Medtronic Neurosurgery | GXQ |
| Jun 26, 2006 | K061487 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE Collagen Matrix, Inc. | GXQ |
| Sep 14, 2005 | K052211 | DUREPAIR DURA REGENERATION MATRIX Medtronic Neurosurgery | GXQ |
| Jan 12, 2005 | K043427 | DURAGEN II DURAL REGENERATION MATRIX Integra Lifesciences Corp. | GXQ |
| Dec 1, 2004 | K040888 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE Collagen Matrix, Inc. | GXQ |
| Jul 27, 2004 | K041000 | DUREPAIR DURA REGENERATION MATRIX Medtronic Neurosurgery | GXQ |
| Jun 22, 2004 | K041518 | CODMAN DURAFORM DURAL GRAFT IMPLANT Codman & Shurtleff, Inc. | GXQ |
| Sep 30, 2003 | K032693 | DURAGEN PLUS DURAL GRAFT MATRIX Integra Lifesciences Corp. | GXQ |
| Sep 8, 2003 | K031850 | DURASIS DURAL SUBSTITUTE Cook Biotech, Inc. | GXQ |
| Nov 8, 2002 | K021477 | PRECLUDE MVP DURA SUBSTITUTE W. L. Gore & Associates, Inc. | GXQ |
| May 2, 2000 | K982101 | SHELHIGH NO-REACT DURA SHIELD Shelhigh, Inc. | GXQ |
| Mar 13, 2000 | K991413 | CODMAN ETHISORB DURA PATCH Johnson & Johnson Professionals, Inc. | GXQ |
| Jul 6, 1999 | K982180 | DURAGEN DURAL GRAFT MATRIX Integra Lifesciences Corp. | GXQ |
| Mar 15, 1999 | K984534 | PRECLUDE ACUSEAL DURA SUBSTITUTE W. L. Gore & Associates, Inc. | GXQ |
| Jul 30, 1998 | K982282 | DURA-GUARD - DURAL REPAIR PATCH Bio-Vascular, Inc. | GXQ |
| May 13, 1998 | K980548 | DURA-PATCH MODEL DP-XXX Bridger Biomed, Inc. | GXQ |
| Dec 24, 1997 | K973706 | DURA-GUARD-DURAL REPAIR PATCH Bio-Vascular, Inc. | GXQ |
| Dec 9, 1997 | K970851 | LYOPLANT DURA SUBSTITUTE(VARIOUS) Aesculap, Inc. | GXQ |
| May 10, 1996 | K960470 | NEURO-PATCH Aesculap, Inc. | GXQ |
| Nov 1, 1995 | K953969 | PRECLUDE DURA SUBSTITUTE W. L. Gore & Associates, Inc. | GXQ |
| Jun 2, 1995 | K950956 | DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE Bio-Vascular, Inc. | GXQ |
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