OrthoPediatrics Cannulated Screw System

OrthoPediatrics Cannulated Screw System is an FDA 510(k)-cleared medical device (K190324) 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 July 4, 2019. Regulation: 8.