ORTHO DEVELOPMENT BALANCED KNEE SYSTEM

ORTHO DEVELOPMENT BALANCED KNEE SYSTEM is an FDA 510(k)-cleared medical device (K994370) manufactured by Ortho Development Corp.. 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 23, 2000. Regulation: 8.