Fusion FibFix Nail

Fusion FibFix Nail is an FDA 510(k)-cleared medical device (K252961) manufactured by Fusion Orthopedics USA, 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 March 17, 2026. Regulation: 8.