Atlas FDA

GXQ

43 FDA 510(k) clearances · Product code

99 daysmedian time to decision
269 days90th percentile
43clearances measured

FDA profile

Official device name
Dura Substitute
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5910
Medical specialty
Neurology
Flags
Implant
Adverse events (MAUDE)
2021: 76 · 2022: 59 · 2023: 109 · 2024: 55 · 2025: 63 · 2026: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Collagen Dura Regeneration Membrane - Repair (K251191)Collagen Matrix, Inc.2025-11-18
Helios Dura Regeneration Matrix (K250420)Helios Biomedical, Inc.2025-05-14
ArtiFascia (K223445)Nurami Medical , Ltd.2023-08-10
SyntheCel Dura Repair (K212943)Synthes (USA) Products, LLC2022-01-28
XenoSure Dura Biologic Patch (K183513)LeMaitre Vascular, Inc.2019-06-13
Cerafix Dura Substitute (K172603)Acera Surgical, Inc.2017-11-27
DuraGen Secure Dural Regeneration Matrix (K163456)Integra LifeSciences Corporation2017-01-06
Durepair Dura Regeneration Matrix (K161370)Medtronic Neurosurgery2016-11-02
Cerafix Dura Substitute (K161278)Acera Surgical, Inc.2016-08-08
Cerafix Dura Substitute (K153613)Acera Surgical, Inc.2016-03-16
Collagen Dural Regeneration Matrix (K150825)Collagen Matrix, Inc.2015-11-20
DURAFORM Dural Graft Implant (K152481)Codman & Shurtleff, Inc.2015-10-30
COLLAGEN DURA MEMBRANE (K141608)Collagen Matrix, Inc.2015-01-16
BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM (K132850)Rti Surgical, Inc.2014-03-31
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY (K131792)Synthes, Inc.2013-12-16
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT (K131015)Cook Biotech, Inc.2013-10-08
LYOPLANT ONLAY (K122791)Aesculap, Inc.2013-06-04
DURAGEN SECURE DURAL REGNERATION MATRIX (K120600)Integra Life Sciences2012-06-15
SYNTHECEL DURA REPLACEMENT DEVICES (K113071)Synthes2012-01-09
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO (K092388)Integra LifeSciences Corporation2010-01-21
DURAGEN XS DURAL REGENERATION MATRIX (K072207)Integra Lifesciences Corp.2007-08-23
LIFECELL DURAL SUBSTITUTE MATRIX (K061208)Lifecell Corp.2007-01-03
MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX (K063117)Medtronic Neurosurgery2006-11-03
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE (K061487)Collagen Matrix, Inc.2006-06-26
DUREPAIR DURA REGENERATION MATRIX (K052211)Medtronic Neurosurgery2005-09-14
DURAGEN II DURAL REGENERATION MATRIX (K043427)Integra Lifesciences Corp.2005-01-12
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE (K040888)Collagen Matrix, Inc.2004-12-01
DUREPAIR DURA REGENERATION MATRIX (K041000)Medtronic Neurosurgery2004-07-27
CODMAN DURAFORM DURAL GRAFT IMPLANT (K041518)Codman & Shurtleff, Inc.2004-06-22
DURAGEN PLUS DURAL GRAFT MATRIX (K032693)Integra Lifesciences Corp.2003-09-30
DURASIS DURAL SUBSTITUTE (K031850)Cook Biotech, Inc.2003-09-08
PRECLUDE MVP DURA SUBSTITUTE (K021477)W. L. Gore & Associates, Inc.2002-11-08
SHELHIGH NO-REACT DURA SHIELD (K982101)Shelhigh, Inc.2000-05-02
CODMAN ETHISORB DURA PATCH (K991413)Johnson & Johnson Professionals, Inc.2000-03-13
DURAGEN DURAL GRAFT MATRIX (K982180)Integra Lifesciences Corp.1999-07-06
PRECLUDE ACUSEAL DURA SUBSTITUTE (K984534)W. L. Gore & Associates, Inc.1999-03-15
DURA-GUARD - DURAL REPAIR PATCH (K982282)Bio-Vascular, Inc.1998-07-30
DURA-PATCH MODEL DP-XXX (K980548)Bridger Biomed, Inc.1998-05-13
DURA-GUARD-DURAL REPAIR PATCH (K973706)Bio-Vascular, Inc.1997-12-24
LYOPLANT DURA SUBSTITUTE(VARIOUS) (K970851)Aesculap, Inc.1997-12-09
NEURO-PATCH (K960470)Aesculap, Inc.1996-05-10
PRECLUDE DURA SUBSTITUTE (K953969)W. L. Gore & Associates, Inc.1995-11-01
DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE (K950956)Bio-Vascular, Inc.1995-06-02

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