APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT

APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT is an FDA 510(k)-cleared medical device (K934381) manufactured by Intermedics Orthopedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 7, 1995. Regulation: 8.