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

    Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm

    K Number: K213454 · Decision Nov 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    64
    Applicant Total
    9
    Review Days
    28

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    Basic Information

    Device Name
    Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
    K Number
    K213454
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Powered Surgical Solutions
    Date Received
    October 26, 2021
    Decision Date
    November 23, 2021
    Product Code
    HBE
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

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    Other Clearances by Medtronic Powered Surgical Solutions

    K Number Device Name
    K183644 Stealth-Midas MR8 System
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    K170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
    K163565 MR8 Drill System
    K163182 Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
    K160713 Stealth-Midas System
    K090112 MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700
    K072315 MIDAS REX CURVED BUR