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Bm Korea Co., Ltd.
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SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K120353) manufactured by Bm Korea 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 May 8, 2012. Regulation: 8.