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Biomet Manufacturing Corp
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ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES is an FDA 510(k)-cleared medical device (K083827) manufactured by Biomet Manufacturing Corp. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 2009. Regulation: 8.