DeGen Medical E3 MIS Pedicle Screw System

DeGen Medical E3 MIS Pedicle Screw System is an FDA 510(k)-cleared medical device (K173814) manufactured by Degen Medical. 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 28, 2018. Regulation: 8.