510(k) K170312

IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools by Medtronic Powered Surgical Solutions — Product Code HBC

K170312 is an FDA 510(k) premarket notification submitted by Medtronic Powered Surgical Solutions for the device "IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools". The FDA issued a decision of Substantially Equivalent on May 15, 2017. The device falls under product code HBC (Motor, Drill, Electric), a Class II device regulated under 21 CFR 882.4360. Medtronic Powered Surgical Solutions has at least 8 other 510(k) clearances on record.