T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System is an FDA 510(k)-cleared medical device (K162358) 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 October 31, 2016. Regulation: 8.