510(k) K133785

TRITIUM STERNAL CABLE PLATE SYSTEM by Pioneer Surgical Technology, Inc. — Product Code JDQ

K133785 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. for the device "TRITIUM STERNAL CABLE PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 27, 2014. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Pioneer Surgical Technology, Inc. has at least 10 other 510(k) clearances on record.