Response BandLoc Spinal Fixation

Response BandLoc Spinal Fixation is an FDA 510(k)-cleared medical device (K200097) 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 15, 2020. Regulation: 8.