PROSTEP MICA Screw System

PROSTEP MICA Screw System is an FDA 510(k)-cleared medical device (K181377) 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 January 10, 2019. Regulation: 8.