EUROPA Pedicle Screw System

EUROPA Pedicle Screw System is an FDA 510(k)-cleared medical device (K180337) manufactured by MiRus, LLC. 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 13, 2019. Regulation: 8.