Iliad® Pedicle Screw System and Zenius® Pedicle Screw System

Iliad® Pedicle Screw System and Zenius® Pedicle Screw System is an FDA 510(k)-cleared medical device (K171509) manufactured by Medyssey USA, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 11, 2017. Regulation: 8.