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Dvo Extremity Solutions, LLC
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TOTAL AND HEMI SHOULDER SYSTEM is an FDA 510(k)-cleared medical device (K060988) manufactured by Dvo Extremity Solutions, 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 December 5, 2006. Regulation: 8.