INCLUSICE II(TM) ENDOSCOPE

INCLUSICE II(TM) ENDOSCOPE is an FDA 510(k)-cleared medical device (K946087) manufactured by Sofamor Danek USA,Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 20, 1995. Regulation: 8.