MIS Precision Chevron Bunion System

MIS Precision Chevron Bunion System is an FDA 510(k)-cleared medical device (K211628) manufactured by Relja Innovations, 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 January 30, 2022. Regulation: 8.