Cleared Traditional

K061208 - LIFECELL DURAL SUBSTITUTE MATRIX

K061208 is an FDA 510(k) clearance for LIFECELL DURAL SUBSTITUTE MATRIX, manufactured by Lifecell Corp.. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K061208 · Lifecell Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
247d
Days
Class 2
Risk

K061208 is an FDA 510(k) clearance for the LIFECELL DURAL SUBSTITUTE MATRIX. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Lifecell Corp. (Branchburg, US). The FDA issued a Cleared decision on January 3, 2007 after a review of 247 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 Lifecell Corp. devices

FDA 510(k) Submission Details - K061208

510(k) Number K061208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2006
Decision Date January 03, 2007
Days to Decision 247 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 148d · This submission: 247d
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 33
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K061208.
LYOPLANT ONLAY
K122791 · Aesculap, Inc. · Jun 2013
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
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
DUREPAIR DURA REGENERATION MATRIX
K052211 · Medtronic Neurosurgery · Sep 2005