RESPONSE™ Rib and Pelvic System

RESPONSE™ Rib and Pelvic System is an FDA 510(k)-cleared medical device (K233105) 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 January 19, 2024. Regulation: 8.