RESPONSE 5.5/6.0 Cannulated Screw System

RESPONSE 5.5/6.0 Cannulated Screw System is an FDA 510(k)-cleared medical device (K222105) 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 March 22, 2023. Regulation: 8.