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Biomet Trauma
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BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL is an FDA 510(k)-cleared medical device (K091976) manufactured by Biomet Trauma. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 16, 2009. Regulation: 8.