The Acumed Wrist Fixation System - 2.4mm Screws

The Acumed Wrist Fixation System - 2.4mm Screws is an FDA 510(k)-cleared medical device (K252356) manufactured by Acumed, 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 August 20, 2025. Regulation: 8.