BALANCED KNEE SYSTEM REVISION OFFSET TIBIA

BALANCED KNEE SYSTEM REVISION OFFSET TIBIA is an FDA 510(k)-cleared medical device (K103837) manufactured by Ortho Development. 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, 2011. Regulation: 8.