Cleared Traditional

BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM

K132850 · Rti Surgical, Inc. · Neurology
Mar 2014
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K132850 is an FDA 510(k) clearance for the BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM, a Dura Substitute (Class II — Special Controls, product code GXQ), submitted by Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on March 31, 2014, 201 days after receiving the submission on September 11, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number K132850 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2013
Decision Date March 31, 2014
Days to Decision 201 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