Cleared Traditional

Collagen Dural Regeneration Matrix

K150825 · Collagen Matrix, Inc. · Neurology
Nov 2015
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K150825 is an FDA 510(k) clearance for the Collagen Dural Regeneration Matrix, a Dura Substitute (Class II — Special Controls, product code GXQ), submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on November 20, 2015, 238 days after receiving the submission on March 27, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number K150825 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2015
Decision Date November 20, 2015
Days to Decision 238 days
Submission Type Traditional
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