StealthFix Intraosseous Fixation System

StealthFix Intraosseous Fixation System is an FDA 510(k)-cleared medical device (K220181) manufactured by Nextremity 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 March 21, 2022. Regulation: 8.