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510(k) Data Aggregation

    K Number
    K131264
    Date Cleared
    2013-07-26

    (84 days)

    Product Code
    Regulation Number
    888.3040
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

    Device Description

    Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or a study demonstrating that a device meets acceptance criteria. The document is a 510(k) summary for Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws, outlining its indications for use, device description, and substantial equivalence to predicate devices. It also includes an FDA response confirming substantial equivalence.

    Therefore, I cannot provide the requested table or answer the specific questions about a study based on the given information.

    To answer your request, a document detailing device performance data, acceptance criteria, and specific study methodologies would be required.

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