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510(k) Data Aggregation

    K Number
    K111155
    Device Name
    XTRAFIX EXTERNAL FIXATION SYSTEM
    Manufacturer
    EXTRAORTHO INC
    Date Cleared
    2011-10-20

    (178 days)

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

    EXTRAORTHO INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XtraFix 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 XtraFix 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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