MARK I & II TOTAL KNEE REPLACE. SYS

MARK I & II TOTAL KNEE REPLACE. SYS is an FDA 510(k)-cleared medical device (K830726) manufactured by Advanced Biosearch Assn.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 1983. Regulation: 8.