Tritium Sternal Cable Plate System

Tritium Sternal Cable Plate System is an FDA 510(k)-cleared medical device (K193468) 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 March 11, 2020. Regulation: 8.