DePuy Synthes T-PAL Spacer System

DePuy Synthes T-PAL Spacer System is an FDA 510(k)-cleared medical device (K181231) manufactured by Depuy Synthes Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 5, 2018. Regulation: 8.