DePuy Synthes 2.0 mm Quick Insertion Screws

DePuy Synthes 2.0 mm Quick Insertion Screws is an FDA 510(k)-cleared medical device (K180541) manufactured by Synthes USA Products, 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 November 20, 2018. Regulation: 8.