INBONE ( I AND II) TOTAL ANKLE SYSTEMS

INBONE ( I AND II) TOTAL ANKLE SYSTEMS is an FDA 510(k)-cleared medical device (K123059) manufactured by Wrightmedicaltechnologyinc. 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 3, 2013. Regulation: 8.