Cleared Traditional

K092388 - DURAGEN PLUS DURAL REGENERATION MATRIX-...

K092388 is the FDA 510(k) clearance for DURAGEN PLUS DURAL REGENERATION MATRIX-... by Integra LifeSciences Corporation. It is a Class 2 Neurology device (product code GXQ) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K092388 · Integra LifeSciences Corporation · Neurology device
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Jan 2010
Decision
169d
Days
Class 2
Risk

K092388 is an FDA 510(k) clearance for the DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGR.... Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on January 21, 2010 after a review of 169 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 Integra LifeSciences Corporation devices

Submission Details

510(k) Number K092388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2009
Decision Date January 21, 2010
Days to Decision 169 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
21d slower than avg
Panel avg: 148d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 19
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K092388.
DURAFORM Dural Graft Implant
K152481 · Codman & Shurtleff, Inc. · Oct 2015
COLLAGEN DURA MEMBRANE
K141608 · Collagen Matrix, Inc. · Jan 2015
LYOPLANT ONLAY
K122791 · Aesculap, Inc. · Jun 2013
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
K061487 · Collagen Matrix, Inc. · Jun 2006
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
K040888 · Collagen Matrix, Inc. · Dec 2004
CODMAN DURAFORM DURAL GRAFT IMPLANT
K041518 · Codman & Shurtleff, Inc. · Jun 2004