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Bk Meditech, Co., Ltd.
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DYNA-EXTOR II is an FDA 510(k)-cleared medical device (K110426) manufactured by Bk Meditech, 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 November 1, 2011. Regulation: 8.