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Synthes USA
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2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM is an FDA 510(k)-cleared medical device (K110125) manufactured by Synthes USA. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 2011. Regulation: 8.