TOTAL CONDYLAT TYPE KNEE SYSTEM

TOTAL CONDYLAT TYPE KNEE SYSTEM is an FDA 510(k)-cleared medical device (K922869) manufactured by Osteo Technology, 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 July 12, 1993. Regulation: 8.