REXIOUS HOOK FIXATION SYSTEMS

REXIOUS HOOK FIXATION SYSTEMS is an FDA 510(k)-cleared medical device (K113324) manufactured by Dio Medical Co., Ltd.. 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 27, 2012. Regulation: 8.