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

    LOADPRO™ Intraoperative Rod Strain Sensor

    K Number: DEN180012 · Decision Mar 28, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    379

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    Basic Information

    Device Name
    LOADPRO™ Intraoperative Rod Strain Sensor
    K Number
    DEN180012
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    888.3090
    Medical Specialty
    Orthopedic
    Decision
    Unknown
    Applicant
    Intellirod Spine, Inc.
    Date Received
    March 14, 2018
    Decision Date
    March 28, 2019
    Product Code
    QFP
    Advisory Committee
    Orthopedic
    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
    QFP Intraoperative Orthopedic Strain Sensor