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Titan Spine, LLC
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ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) is an FDA 510(k)-cleared medical device (K080615) manufactured by Titan Spine, 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 June 16, 2008. Regulation: 8.