Response 5.5/6.0 Spine System

Response 5.5/6.0 Spine System is an FDA 510(k)-cleared medical device (K150600) 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 May 21, 2015. Regulation: 8.