
Stryker Orthopaedics
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SHORT CITATION FEMORAL STEM is an FDA 510(k)-cleared medical device (K053528) manufactured by Stryker Orthopaedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 12, 2006. Regulation: 8.