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Blackstone Medical, Inc.
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HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES is an FDA 510(k)-cleared medical device (K100614) manufactured by Blackstone Medical, Inc.. 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 3, 2010. Regulation: 8.