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510(k) Data Aggregation

    K Number
    K100736
    Device Name
    KIRSCHNER AND GUIDE WIRES
    Manufacturer
    SMT SCHILLING METALLTECHNIK GMBH
    Date Cleared
    2010-09-10

    (179 days)

    Product Code
    HTY, JDW
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMT SCHILLING METALLTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthopaedic fixation pins and wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.
    Device Description
    Orthopaedic fixation pins and wires are metal pins for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implantation through the skin so that traction may be applied to the skeleton system. To ensure the multi-use of these devices, many different models are available. The differences can be as follows: Diameter: from 0.6 up to 6.35mm (0.020 up to 0.250 inch) Length: from 60 up to 500 mm (2.36 up to 19.69 inch) Tips: diamond or trocar Point, round, flat, with or without 3- or 4- shank ends, with or without spherical shape. Surface: complete or partial smooth and / or threaded, with or without threading cutter.
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