Nanovis Intervertebral Body Fusion System and Forticore(R)

Nanovis Intervertebral Body Fusion System and Forticore(R) is an FDA 510(k)-cleared medical device (K161485) manufactured by Nanovis, 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 September 5, 2016. Regulation: 8.