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    K Number
    K063589
    Device Name
    GSO BONE FIXATION FASTENERS
    Manufacturer
    GOLD STANDARD ORTHOPAEDICS LLC
    Date Cleared
    2007-01-31

    (61 days)

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

    GOLD STANDARD ORTHOPAEDICS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GSO Bone Fixation Fasteners 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. ** Warning: GSO Bone Fixation Devices are not indicated for spinal fixation. **
    Device Description
    The GSO Bone Fixation Fasteners consist of sterile and non-sterile, single-use, smooth and threaded Kirschner wires and Steinmann pins (ranging in length from 4 to 12 inches and in diameter from 0.028 to 0.177 inches), and cortical, cancellous, and malleolar bone screws (ranging in length from 6 to 160 mm and in screw diameter from 1.5 to 6.5mm). All GSO Bone Fixation Fasteners are manufactured from 316-LVM stainless steel conforming to standard ASTM-F138.
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