K132850

Substantially Equivalent

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

Applicant: Rti Surgical, Inc.
Product 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

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.