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510(k) Data Aggregation

    K Number
    K091258
    Device Name
    EXTRAFIX EXTERNAL FIXATION SYSTEM
    Manufacturer
    QFX TECHNOLOGIES, INC.
    Date Cleared
    2009-07-24

    (86 days)

    Product Code
    KTT, JDW
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    QFX TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extrafix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone ( foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for: - Temporary stabilization of open or closed acute fractures with soft tissue injuries; . - Definitive stabilization of open or closed fractures where open or alternative closed # treatment is undesirable or otherwise contraindicated; - Stabilization of fractures in the context of polytrauma; . - Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries; - Arthrodesis and osteotomies with associated soft tissue problems; . - Stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for . infection or other failure; - Neutralization of fractures stabilized with limited internal fixation; . - Stabilization of non-unions; and - Intraoperative temporary stabilization tool to assist with indirect reduction.
    Device Description
    The Extrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.
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