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Theken Spine, LLC
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CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE is an FDA 510(k)-cleared medical device (K102323) manufactured by Theken 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 December 15, 2010. Regulation: 8.