GXQ · Class II · 21 CFR 882.5910

FDA Product Code GXQ: Dura Substitute

Leading manufacturers include Collagen Matrix, Inc., Integra Lifesciences Corp. and Medtronic Neurosurgery.

43
Total
43
Cleared
146d
Avg days
1995
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Consistent review times: 153d avg (recent)

FDA 510(k) Cleared Dura Substitute Devices (Product Code GXQ)

43 devices
1–24 of 43
Cleared Nov 18, 2025
Collagen Dura Regeneration Membrane - Repair
K251191
Collagen Matrix, Inc.
Neurology · 215d
Cleared May 14, 2025
Helios Dura Regeneration Matrix
K250420
Helios Biomedical, Inc.
Neurology · 90d
Cleared Aug 10, 2023
ArtiFascia
K223445
Nurami Medical , Ltd.
Neurology · 269d
Cleared Jan 28, 2022
SyntheCel Dura Repair
K212943
Synthes USA Products, LLC
Neurology · 135d
Cleared Jun 13, 2019
XenoSure Dura Biologic Patch
K183513
LeMaitre Vascular, Inc.
Neurology · 177d
Cleared Nov 27, 2017
Cerafix Dura Substitute
K172603
Acera Surgical, Inc.
Neurology · 89d
Cleared Jan 06, 2017
DuraGen Secure Dural Regeneration Matrix
K163456
Integra LifeSciences Corporation
Neurology · 28d
Cleared Nov 02, 2016
Durepair Dura Regeneration Matrix
K161370
Medtronic Neurosurgery
Neurology · 169d
Cleared Aug 08, 2016
Cerafix Dura Substitute
K161278
Acera Surgical, Inc.
Neurology · 94d
Cleared Mar 16, 2016
Cerafix Dura Substitute
K153613
Acera Surgical, Inc.
Neurology · 90d
Cleared Nov 20, 2015
Collagen Dural Regeneration Matrix
K150825
Collagen Matrix, Inc.
Neurology · 238d
Cleared Oct 30, 2015
DURAFORM Dural Graft Implant
K152481
Codman & Shurtleff, Inc.
Neurology · 60d
Cleared Jan 16, 2015
COLLAGEN DURA MEMBRANE
K141608
Collagen Matrix, Inc.
Neurology · 214d
Cleared Mar 31, 2014
BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
K132850
Rti Surgical, Inc.
Neurology · 201d
Cleared Dec 16, 2013
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
K131792
Synthes, Inc.
Neurology · 181d
Cleared Oct 08, 2013
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
K131015
Cook Biotech, Inc.
Neurology · 180d
Cleared Jun 04, 2013
LYOPLANT ONLAY
K122791
Aesculap, Inc.
Neurology · 265d
Cleared Jun 15, 2012
DURAGEN SECURE DURAL REGNERATION MATRIX
K120600
Integra Life Sciences
Neurology · 108d
Cleared Jan 09, 2012
SYNTHECEL DURA REPLACEMENT DEVICES
K113071
Synthes
Neurology · 84d
Cleared Jan 21, 2010
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
K092388
Integra LifeSciences Corporation
Neurology · 169d
Cleared Aug 23, 2007
DURAGEN XS DURAL REGENERATION MATRIX
K072207
Integra Lifesciences Corp.
Neurology · 15d
Cleared Nov 03, 2006
MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
K063117
Medtronic Neurosurgery
Neurology · 22d
Cleared Jun 26, 2006
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
K061487
Collagen Matrix, Inc.
Neurology · 26d
Cleared Sep 14, 2005
DUREPAIR DURA REGENERATION MATRIX
K052211
Medtronic Neurosurgery
Neurology · 30d

About Product Code GXQ - Regulatory Context

510(k) Submission Activity

43 total 510(k) submissions under product code GXQ since 1995, with 43 receiving FDA clearance (average review time: 146 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GXQ Product Code

FDA review times for GXQ submissions have been consistent, averaging 153 days recently vs 146 days historically.

GXQ devices are reviewed by the Neurology panel. Browse all Neurology devices →