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Ebi,Llc D/B/A Biomet Trauma
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BIODRIVE MICRO SCREW SYSTEM is an FDA 510(k)-cleared medical device (K092670) manufactured by Ebi,Llc D/B/A 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 November 18, 2009. Regulation: 8.