
Encore Medical L.P.
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REVERSE SHOULDER PROSTHESIS MONOBLOCK is an FDA 510(k)-cleared medical device (K130048) manufactured by Encore Medical L.P.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 28, 2013. Regulation: 8.