Nanovis Intervertebral Body Fusion System and FortiCore®

Nanovis Intervertebral Body Fusion System and FortiCore® is an FDA 510(k)-cleared medical device (K160874) 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 June 27, 2016. Regulation: 8.