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510(k) Data Aggregation

    K Number
    K052901
    Device Name
    ARTHREX TENSIONLOK
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2005-12-12

    (59 days)

    Product Code
    HRS,GAT
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K031666
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arthrex TensionLok™ for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension, intended as a fixation pool, a dicinemation of the summer will be offering this for ACL repair.

    Device Description

    The Arthrex TensionLok™is a Titanium button per F136 available with pre-threaded FiberWire® suture.

    AI/ML Overview

    The provided text is a 510(k) summary for the Arthrex TensionLok™ device, a medical device for bone fixation. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include any information about acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    Therefore, I cannot provide the requested table and information as it is not present in the given text.

    No information regarding acceptance criteria or a study proving the device meets acceptance criteria is present in the provided document.

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