Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)

Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) is an FDA 510(k)-cleared medical device (K150099) 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 March 22, 2015. Regulation: 8.