Acumed Acutrak 3 Headless Compression Screw System

Acumed Acutrak 3 Headless Compression Screw System is an FDA 510(k)-cleared medical device (K230744) 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 June 8, 2023. Regulation: 8.