DePuy Synthes TFNA Augmentation System

DePuy Synthes TFNA Augmentation System is an FDA 510(k)-cleared medical device (K160167) 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 September 25, 2016. Regulation: 8.