Cleared Traditional

K150825 - Collagen Dural Regeneration Matrix

K150825 is an FDA 510(k) clearance for Collagen Dural Regeneration Matrix, manufactured by Collagen Matrix, Inc.. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K150825 · Collagen Matrix, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
238d
Days
Class 2
Risk

K150825 is an FDA 510(k) clearance for the Collagen Dural Regeneration Matrix. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on November 20, 2015 after a review of 238 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5910 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Collagen Matrix, Inc. devices

FDA 510(k) Submission Details - K150825

510(k) Number K150825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2015
Decision Date November 20, 2015
Days to Decision 238 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 148d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXQ Device Classification - Class 2, Special Controls

Product Code GXQ Dura Substitute
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXQ Dura Substitute

All 41
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K150825.
Durepair Dura Regeneration Matrix
K161370 · Medtronic Neurosurgery · Nov 2016
Cerafix Dura Substitute
K161278 · Acera Surgical, Inc. · Aug 2016
Cerafix Dura Substitute
K153613 · Acera Surgical, Inc. · Mar 2016
DURAFORM Dural Graft Implant
K152481 · Codman & Shurtleff, Inc. · Oct 2015
COLLAGEN DURA MEMBRANE
K141608 · Collagen Matrix, Inc. · Jan 2015
BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
K132850 · Rti Surgical, Inc. · Mar 2014