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    FDA 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

    FDA 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

    $149.00 USD
    $149.00 USD
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    510(K) Number: K161210
    Device Name: 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
    Manufacturer: Medtronic Sofamor Danek
    Device Classification Name: sacroiliac joint fixation
    Regulation Number: 888.3040
    Classification Product Code: OUR
    Date Received: 04/28/2016
    Decision Date: 08/12/2016
    Regulation Medical Specialty: Orthopedic

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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