INSALL/BURSTEIN(TM)* II TIBIAL WEDGES

INSALL/BURSTEIN(TM)* II TIBIAL WEDGES is an FDA 510(k)-cleared medical device (K862632) manufactured by Zimmer, 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 March 24, 1987. Regulation: 8.