
D.K.M. Co., Ltd.
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GLOBAL SPINAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K001668) manufactured by D.K.M. 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 October 18, 2000. Regulation: 8.