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Blackstone Medical, Inc.
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BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM is an FDA 510(k)-cleared medical device (K030595) 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 April 23, 2003. Regulation: 8.