510(k) K132850

BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM by Rti Surgical, Inc. — Product Code GXQ

K132850 is an FDA 510(k) premarket notification submitted by Rti Surgical, Inc. for the device "BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM". The FDA issued a decision of Substantially Equivalent on March 31, 2014. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Rti Surgical, Inc. has at least 6 other 510(k) clearances on record.