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Stryker Trauma AG
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SUPERIOR LATERAL VARIAX CLAVICLE PLATE is an FDA 510(k)-cleared medical device (K130116) manufactured by Stryker Trauma AG. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 4, 2013. Regulation: 8.