PhaLinx Hammertoe System

PhaLinx Hammertoe System is an FDA 510(k)-cleared medical device (K142585) 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 November 19, 2014. Regulation: 8.