Tritium® Sternal Cable Plate System

Tritium® Sternal Cable Plate System is an FDA 510(k)-cleared medical device (K161876) manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. 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 8, 2016. Regulation: 8.