DigiFix Sterile Kit

DigiFix Sterile Kit is an FDA 510(k)-cleared medical device (K192465) manufactured by Virak Orthopedics, 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 October 9, 2019. Regulation: 8.