The Radian MIS Bunion System

The Radian MIS Bunion System is an FDA 510(k)-cleared medical device (K211650) manufactured by Nvision Biomedical Technologies, Inc.. 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 23, 2021. Regulation: 8.