Cleared Special

K063117 - MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX

K063117 is an FDA 510(k) clearance for MODIFICATION TO DUREPAIR DURA REGENERAT..., manufactured by Medtronic Neurosurgery. The device is a Class 2 Neurology device with product code GXQ cleared through the Special 510(k) pathway after a 22-day FDA review.

K063117 · Medtronic Neurosurgery · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
22d
Days
Class 2
Risk

K063117 is an FDA 510(k) clearance for the MODIFICATION TO 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 November 3, 2006 after a review of 22 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.

FDA 510(k) Submission Details - K063117

510(k) Number K063117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2006
Decision Date November 03, 2006
Days to Decision 22 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
127d faster than avg
Panel avg: 149d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 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 42
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K063117.
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
K092388 · Integra LifeSciences Corporation · Jan 2010
DURAGEN XS DURAL REGENERATION MATRIX
K072207 · Integra Lifesciences Corp. · Aug 2007
LIFECELL DURAL SUBSTITUTE MATRIX
K061208 · Lifecell Corp. · Jan 2007
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
K061487 · Collagen Matrix, Inc. · Jun 2006
DUREPAIR DURA REGENERATION MATRIX
K052211 · Medtronic Neurosurgery · Sep 2005
DURAGEN II DURAL REGENERATION MATRIX
K043427 · Integra Lifesciences Corp. · Jan 2005
K063117 · MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
Download PDF FDA Summary Medtronic Neurosurgery