INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE

INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE is an FDA 510(k)-cleared medical device (K093808) 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 March 23, 2010. Regulation: 8.