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510(k) Data Aggregation

    K Number
    K083912
    Device Name
    TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS
    Manufacturer
    TREU-INSTRUMENTE GMBH
    Date Cleared
    2009-07-15

    (197 days)

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

    TREU-INSTRUMENTE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Treu Bone Fixation Screws and Pins are intended to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.
    Device Description
    Treu Bone Screws are available in thread diameters ranging from ø1.5 mm to ø7 mm, lengths ranging from 6 mm to 130 mm, are either cannulated or non-cannulated and made of stainless steel or titanium alloy. Treu Schanz Screws are available in wire diameters ranging from ø3.0 mm to ø6.0 mm, lengths ranging from 60 mm to 350 mm, thread lengths ranging from 20 mm and are made of stainless steel. Treu Kirschner Wires are available in wire diameters ranging from ø0.8 mm to ø3.0 mm, lengths ranging from 70 mm to 500 mm, are partially or completely smooth or threaded and are made of stainless steel. Treu Steinmann Pins are available in wire diameters ranging from ø3.0 mm to ø6.0 mm, lengths ranging from 80 mm to 500 mm, are partially or completely smooth or threaded and are made of stainless steel. Treu Larsen Pins are available in one diameter (ø1.6 mm) and four lengths (60, 80, 100, 120 mm). The head of the pin is 2.5 mm thick and the anchoring hole is ø1.2 mm to facilitate a ø1 mm cerclage wire. The proximal part of the Larsen Pin is prepared for cutting and fits in conventional as well as mini drivers.
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