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Stryker Corporation
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SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS is an FDA 510(k)-cleared medical device (K103124) manufactured by Stryker 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 November 18, 2010. Regulation: 8.