Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System

Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System is an FDA 510(k)-cleared medical device (K181390) 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 17, 2018. Regulation: 8.