
Synthes (Usa)
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SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM is an FDA 510(k)-cleared medical device (K072578) 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 November 27, 2007. Regulation: 8.