510(k) K161210

RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems by Medtronic Sofamor Danek — Product Code OUR

K161210 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek for the device "RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems". The FDA issued a decision of Substantially Equivalent on August 12, 2016. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Medtronic Sofamor Danek has at least 10 other 510(k) clearances on record.