PROFEMUR XM DISTAL CENTRALIZER

PROFEMUR XM DISTAL CENTRALIZER is an FDA 510(k)-cleared medical device (K130167) 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 April 18, 2013. Regulation: 8.