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Biomet Trauma (Aka Ebi, Lp)
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SMPLE PLATE AND SCREWS is an FDA 510(k)-cleared medical device (K093983) manufactured by Biomet Trauma (Aka Ebi, Lp). This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 18, 2010. Regulation: 8.