BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM— 510(k) K132850

Substantially Equivalent

Rti Surgical, Inc.

FDA 510(k) clearance K132850 for BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM, Substantially Equivalent on 2014-03-31. Applicant: Rti Surgical, Inc..

Clearance details

Applicant: Rti Surgical, Inc.
Product code: Code GXQ
Advisory panel: Neurology
Date received: 2013-09-11
Decision date: 2014-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alachua, FL, US

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Adverse events under product code GXQ

product code GXQ

Death: 11
Injury: 446
Other: 1
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.