Cleared Special

K043427 - DURAGEN II DURAL REGENERATION MATRIX
(FDA 510(k) Clearance)

K043427 · Integra Lifesciences Corp. · Neurology
Jan 2005
Decision
30d
Days
Class 2
Risk

K043427 is an FDA 510(k) clearance for the DURAGEN II DURAL REGENERATION MATRIX. This device is classified as a Dura Substitute (Class II — Special Controls, product code GXQ).

Submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on January 12, 2005, 30 days after receiving the submission on December 13, 2004.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number K043427 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2004
Decision Date January 12, 2005
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXQ — Dura Substitute
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5910