BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT

BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT is an FDA 510(k)-cleared medical device (K131015) manufactured by Cook Biotech, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 7, 2013. Regulation: 8.