Product Code: GXQ FDA class 2 21 CFR 882.5910

Dura Substitute

Neurology

The Dura Substitute is an implanted neurosurgical material used to repair or replace the dura mater, the protective membrane surrounding the brain and spinal cord, following surgical procedures or traumatic injury. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and is designated as an implant. The product code is GXQ under regulation 21 CFR 882.5910 in the Neurology specialty. The implant flag is active for this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GXQ
Device Class: FDA class 2
Regulation Number: 882.5910
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 43 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251191	Collagen Dura Regeneration Membrane - Repair	Nov 18, 2025	Substantially Equivalent	Collagen Matrix, Inc.
K250420	Helios Dura Regeneration Matrix	May 14, 2025	Substantially Equivalent	Helios Biomedical, Inc.
K223445	ArtiFascia	Aug 10, 2023	Substantially Equivalent	Nurami Medical , Ltd.
K212943	SyntheCel Dura Repair	Jan 28, 2022	Substantially Equivalent	Synthes (USA) Products, LLC
K183513	XenoSure Dura Biologic Patch	Jun 13, 2019	Substantially Equivalent	LeMaitre Vascular, Inc.
K172603	Cerafix Dura Substitute	Nov 27, 2017	Substantially Equivalent	Acera Surgical, Inc.
K163456	DuraGen Secure Dural Regeneration Matrix	Jan 06, 2017	Substantially Equivalent	Integra LifeSciences Corporation
K161370	Durepair Dura Regeneration Matrix	Nov 02, 2016	Substantially Equivalent	Medtronic Neurosurgery
K161278	Cerafix Dura Substitute	Aug 08, 2016	Substantially Equivalent	Acera Surgical, Inc.
K153613	Cerafix Dura Substitute	Mar 16, 2016	Substantially Equivalent	Acera Surgical, Inc.
K150825	Collagen Dural Regeneration Matrix	Nov 20, 2015	Substantially Equivalent	Collagen Matrix, Inc.
K152481	DURAFORM Dural Graft Implant	Oct 30, 2015	Substantially Equivalent	Codman & Shurtleff, Inc.
K141608	COLLAGEN DURA MEMBRANE	Jan 16, 2015	Substantially Equivalent	Collagen Matrix, Inc.
K132850	BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM	Mar 31, 2014	Substantially Equivalent	Rti Surgical, Inc.
K131792	SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY	Dec 16, 2013	Substantially Equivalent	Synthes, Inc.
K131015	BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT	Oct 08, 2013	Substantially Equivalent	Cook Biotech, Inc.
K122791	LYOPLANT ONLAY	Jun 04, 2013	Substantially Equivalent	Aesculap, Inc.
K120600	DURAGEN SECURE DURAL REGNERATION MATRIX	Jun 15, 2012	Substantially Equivalent	Integra Life Sciences
K113071	SYNTHECEL DURA REPLACEMENT DEVICES	Jan 09, 2012	Substantially Equivalent	Synthes
K092388	DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO	Jan 21, 2010	Substantially Equivalent	Integra LifeSciences Corporation
K072207	DURAGEN XS DURAL REGENERATION MATRIX	Aug 23, 2007	Substantially Equivalent	Integra Lifesciences Corp.
K061208	LIFECELL DURAL SUBSTITUTE MATRIX	Jan 03, 2007	Substantially Equivalent	Lifecell Corp.
K063117	MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX	Nov 03, 2006	Substantially Equivalent	Medtronic Neurosurgery
K061487	DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE	Jun 26, 2006	Substantially Equivalent	Collagen Matrix, Inc.
K052211	DUREPAIR DURA REGENERATION MATRIX	Sep 14, 2005	Substantially Equivalent	Medtronic Neurosurgery
K043427	DURAGEN II DURAL REGENERATION MATRIX	Jan 12, 2005	Substantially Equivalent	Integra Lifesciences Corp.
K040888	DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE	Dec 01, 2004	Substantially Equivalent	Collagen Matrix, Inc.
K041000	DUREPAIR DURA REGENERATION MATRIX	Jul 27, 2004	Substantially Equivalent	Medtronic Neurosurgery
K041518	CODMAN DURAFORM DURAL GRAFT IMPLANT	Jun 22, 2004	Substantially Equivalent	Codman & Shurtleff, Inc.
K032693	DURAGEN PLUS DURAL GRAFT MATRIX	Sep 30, 2003	Substantially Equivalent	Integra Lifesciences Corp.
K031850	DURASIS DURAL SUBSTITUTE	Sep 08, 2003	Substantially Equivalent	Cook Biotech, Inc.
K021477	PRECLUDE MVP DURA SUBSTITUTE	Nov 08, 2002	Substantially Equivalent	W. L. Gore & Associates, Inc.
K982101	SHELHIGH NO-REACT DURA SHIELD	May 02, 2000	Substantially Equivalent	Shelhigh, Inc.
K991413	CODMAN ETHISORB DURA PATCH	Mar 13, 2000	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K982180	DURAGEN DURAL GRAFT MATRIX	Jul 06, 1999	Substantially Equivalent	Integra Lifesciences Corp.
K984534	PRECLUDE ACUSEAL DURA SUBSTITUTE	Mar 15, 1999	Substantially Equivalent	W. L. Gore & Associates, Inc.
K982282	DURA-GUARD - DURAL REPAIR PATCH	Jul 30, 1998	Substantially Equivalent	Bio-Vascular, Inc.
K980548	DURA-PATCH MODEL DP-XXX	May 13, 1998	Substantially Equivalent	Bridger Biomed, Inc.
K973706	DURA-GUARD-DURAL REPAIR PATCH	Dec 24, 1997	Substantially Equivalent	Bio-Vascular, Inc.
K970851	LYOPLANT DURA SUBSTITUTE(VARIOUS)	Dec 09, 1997	Substantially Equivalent	Aesculap, Inc.
K960470	NEURO-PATCH	May 10, 1996	Substantially Equivalent	Aesculap, Inc.
K953969	PRECLUDE DURA SUBSTITUTE	Nov 01, 1995	Substantially Equivalent	W. L. Gore & Associates, Inc.
K950956	DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE	Jun 02, 1995	Substantially Equivalent	Bio-Vascular, Inc.