Cleared Traditional

K060952 - COLLAGEN NERVE WRAP

K060952 is an FDA 510(k) clearance for COLLAGEN NERVE WRAP, manufactured by Collagen Matrix, Inc.. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K060952 · Collagen Matrix, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
99d
Days
Class 2
Risk

K060952 is an FDA 510(k) clearance for the COLLAGEN NERVE WRAP. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on July 14, 2006 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5275 - 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.

FDA 510(k) Submission Details - K060952

510(k) Number K060952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2006
Decision Date July 14, 2006
Days to Decision 99 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
50d faster than avg
Panel avg: 149d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXI Device Classification - Class 2, Special Controls

Product Code JXI Cuff, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5275
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 - JXI Cuff, Nerve

All 39
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K060952.
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE
K103081 · Biom'Up Sas · Mar 2012
NEUROLAC(R) NERVE GUIDE
K112267 · Polyganics B.V., · Oct 2011
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331
K100382 · Salumedica, LLC · Aug 2010
NEUROLAC NERVE GUIDE
K050573 · Polyganics B.V., · May 2005
NEURA WRAP NERVE PROTECTOR
K041620 · Integra Lifesciences Corp. · Jul 2004
NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
K032115 · Polyganics B.V., · Oct 2003
K060952 · COLLAGEN NERVE WRAP
Download PDF FDA Summary Collagen Matrix, Inc.