OrthoPediatrics Locking Proximal Femur System Cortical Screws

OrthoPediatrics Locking Proximal Femur System Cortical Screws is an FDA 510(k)-cleared medical device (K162307) manufactured by OrthoPediatrics Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 26, 2016. Regulation: 8.