BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT— 510(k) K131015

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K131015 for BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT, Substantially Equivalent on 2013-10-08. Applicant: Cook Biotech, Inc..

Clearance details

Applicant: Cook Biotech, Inc.
Product code: Code GXQ
Advisory panel: Neurology
Date received: 2013-04-11
Decision date: 2013-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, 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.