BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Stealth-Midas MR8 System

    K Number: K183644 · Decision May 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    9
    Review Days
    147

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    Basic Information

    Device Name
    Stealth-Midas MR8 System
    K Number
    K183644
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Powered Surgical Solutions
    Date Received
    December 26, 2018
    Decision Date
    May 22, 2019
    Product Code
    OLO
    Advisory Committee
    Neurology
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLO Orthopedic Stereotaxic Instrument

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    Other Clearances by Medtronic Powered Surgical Solutions

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    K160713 Stealth-Midas System
    K090112 MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700
    K072315 MIDAS REX CURVED BUR