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Showa Ika Kohgyo Co., Ltd.
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MYKRES SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K071074) manufactured by Showa Ika Kohgyo 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 July 1, 2008. Regulation: 8.