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Incite Innovation, LLC
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INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE is an FDA 510(k)-cleared medical device (K122008) manufactured by Incite Innovation, 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 November 15, 2012. Regulation: 8.