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Biomet Corporation
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COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS is an FDA 510(k)-cleared medical device (K121183) manufactured by Biomet Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 25, 2012. Regulation: 8.