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510(k) Data Aggregation

    K Number
    K142057
    Device Name
    INFIX CANNULATED SCREW SYSTEM
    Manufacturer
    INFIX MEDICAL LLC
    Date Cleared
    2015-01-13

    (168 days)

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

    INFIX MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InFix Cannulated Screw System is generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. InFix Cannulated Screw System is also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections. Accessories implants: The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
    Device Description
    The InFix Cannulated Screw System includes eight cannulated screw specifications and associated washers, which are manufactured from stainless steel and titanium alloy. The cannulated screw is a self-tapping and self-drilling screw with a cancellous thread that can be guided into a position via a guided wire. They are used to aid in the alignment and stabilization of fractures to the skeletal system.
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