ARTHREX IBALANCE TKA SYSTEM

ARTHREX IBALANCE TKA SYSTEM is an FDA 510(k)-cleared medical device (K133854) manufactured by Arthrex, 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 February 26, 2014. Regulation: 8.