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Osseus, LLC
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OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS is an FDA 510(k)-cleared medical device (K040199) manufactured by Osseus, LLC. 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 19, 2004. Regulation: 8.