Arzzt 3.5 / 4.5 Small & Large Fragments System

Arzzt 3.5 / 4.5 Small & Large Fragments System is an FDA 510(k)-cleared medical device (K162507) manufactured by Truemed Group, 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 2, 2017. Regulation: 8.