TriMed Ankle Fixation System

TriMed Ankle Fixation System is an FDA 510(k)-cleared medical device (K243999) manufactured by TriMed, 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 18, 2025. Regulation: 8.