Preference Elite Pedicle Screw System

Preference Elite Pedicle Screw System is an FDA 510(k)-cleared medical device (K162160) manufactured by Amedica Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2016. Regulation: 8.