NanoOrtho NanoKnee® System

NanoOrtho NanoKnee® System is an FDA 510(k)-cleared medical device (K190633) manufactured by Nanoortho, 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 19, 2019. Regulation: 8.