
Blackstone Medical, Inc.
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MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K030241) 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 February 20, 2003. Regulation: 8.