INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL

INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL is an FDA 510(k)-cleared medical device (K810520) 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 25, 1981. Regulation: 8.