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510(k) Data Aggregation

    K Number
    K083490
    Device Name
    BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
    Manufacturer
    BIOPRO, INC.
    Date Cleared
    2009-03-18

    (113 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K110895,K231339
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indications For Use: The BioPro K-Wire is indicated for use in fixation of bone fractures, for bone reconstructions, and 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

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a device called "K-Wire," detailing its regulation, product code, and intended use. It does not include any performance data, study designs, or ground truth information.

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