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510(k) Data Aggregation

    K Number
    K180092
    Device Name
    Intellitorq
    Manufacturer
    Gauthier Biomedical, Inc.
    Date Cleared
    2018-03-08

    (55 days)

    Product Code
    HXC
    Regulation Number
    888.4540
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gauthier Biomedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to indicate the applied torque according to the set target torque value. This device is intended for use in surgical procedures on bone and tissue by a surgeon trained in its intended use.
    Device Description
    Not Found
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