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Trans1 Incorporated
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TRANS1 AXIALIF 2-LEVEL OR II SYSTEM is an FDA 510(k)-cleared medical device (K073643) manufactured by Trans1 Incorporated. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 27, 2008. Regulation: 8.