DePuy Synthes T-PAL Ti Spacer

DePuy Synthes T-PAL Ti Spacer is an FDA 510(k)-cleared medical device (K151276) 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 June 17, 2015. Regulation: 8.