Cleared Special

K072207 - DURAGEN XS DURAL REGENERATION MATRIX
(FDA 510(k) Clearance)

K072207 · Integra Lifesciences Corp. · Neurology
Aug 2007
Decision
15d
Days
Class 2
Risk

K072207 is an FDA 510(k) clearance for the DURAGEN XS DURAL REGENERATION MATRIX, a Dura Substitute (Class II — Special Controls, product code GXQ), submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on August 23, 2007, 15 days after receiving the submission on August 8, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number K072207 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2007
Decision Date August 23, 2007
Days to Decision 15 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