Cleared Special

K052211 - DUREPAIR DURA REGENERATION MATRIX

K052211 is the FDA 510(k) clearance for DUREPAIR DURA REGENERATION MATRIX by Medtronic Neurosurgery. It is a Class 2 Neurology device (product code GXQ) cleared through the Special 510(k) pathway after a 30-day FDA review.

K052211 · Medtronic Neurosurgery · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
30d
Days
Class 2
Risk

K052211 is an FDA 510(k) clearance for the DUREPAIR DURA REGENERATION MATRIX. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Medtronic Neurosurgery (Goleta, US). The FDA issued a Cleared decision on September 14, 2005 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5910 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Neurosurgery devices

Submission Details

510(k) Number K052211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2005
Decision Date September 14, 2005
Days to Decision 30 days
Submission Type Special
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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Integra LifeSciences Corporation
Jacqueline Ferro

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXQ Dura Substitute

All 29
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K052211.
DURAGEN XS DURAL REGENERATION MATRIX
K072207 · Integra Lifesciences Corp. · Aug 2007
MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
K063117 · Medtronic Neurosurgery · Nov 2006
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
K061487 · Collagen Matrix, Inc. · Jun 2006
DURAGEN II DURAL REGENERATION MATRIX
K043427 · Integra Lifesciences Corp. · Jan 2005
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
K040888 · Collagen Matrix, Inc. · Dec 2004
DUREPAIR DURA REGENERATION MATRIX
K041000 · Medtronic Neurosurgery · Jul 2004