SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM

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.