
Phygen, LLC
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LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K112931) manufactured by Phygen, LLC. 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.