510(k) K161876

Tritium® Sternal Cable Plate System by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. — Product Code JDQ

K161876 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. for the device "Tritium® Sternal Cable Plate System". The FDA issued a decision of Substantially Equivalent on Sep 9, 2016. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. has 6 other 510(k) clearances on record.