PROstep(TM) MIS 5mm Chamfer Screw System

PROstep(TM) MIS 5mm Chamfer Screw System is an FDA 510(k)-cleared medical device (K221645) manufactured by Wright Medical Technology. 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 16, 2023. Regulation: 8.