510(k) K150581

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

K150581 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 June 4, 2015. 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 at least 8 other 510(k) clearances on record.