VariTrax Sternal CircumFixation System

VariTrax Sternal CircumFixation System is an FDA 510(k)-cleared medical device (K232986) manufactured by Circumfix Solutions, 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 January 29, 2024. Regulation: 8.