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510(k) Data Aggregation

    K Number
    K163037
    Device Name
    Intra medullary endo-transilluminating device (iMET device)
    Date Cleared
    2017-02-17

    (109 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    WEMED BIO-TECH INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intra medullary endo-Transilluminating device (iMET), together with all its components, is for use in performing interlocking screw holes positioning during intra-medullary nailing procedure. It is designed to assist surgeons who need to fix fractured long bone , such as tibia, femur, or humerus by providing illumination intramedullary for rapid and precise screw holes positioning without using C-arms thus no extra radiation dosage was absorbed.
    Device Description
    The intra medullary endo-transilluminating (iMET) device is designed to aid the positioning of interlocking nails distal screw hole while intra-medullary nailing procedure is performed. It is a device used to assist surgeons who need to fix the fractured bone more efficiently. It is single use and is disposable after the operation. The whole system consists of a LED-embedded guide pin (iMET), connecting cable and a power control box. The iMET will provide essential light source and indicated the route for aiming and tightening interlocking screw. The iMET consists of a LED lamp, a 304 stainless metal tube and a Polyetheretherketone (PEEK) head. The connecting cable is a simple 2 lines cable with custom-made IP67 waterproof connectors for repeated usage under basic disinfection. The power source, control box, provide electric power for LED. It is designed within a metal box. The voltage enhancement and circuit design were applied for controlling high efficiency LED. The power input is DC 4.5V provided by 3 AA batteries and the output is 30mA in maximum. The control box can be reused under basic cleaning process after the operation.
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