PedFuse Pedicle Screw System

PedFuse Pedicle Screw System is an FDA 510(k)-cleared medical device (K143377) manufactured by Spinefrontier, 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 February 11, 2015. Regulation: 8.