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510(k) Data Aggregation

    K Number
    K091619
    Device Name
    ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW)
    Manufacturer
    ANGLEFIX
    Date Cleared
    2009-09-08

    (97 days)

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

    ANGLEFIX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AngleFix T Locking Plate is indicated for temporary stabilization of long bone fractures including: - Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones - Metaphyseal, supracondylar, peri-articular, intra-articular, and intra-articular . condylar fractures - Diaphyseal fractures . - Ankle fractures . - Simple, comminuted and depression fractures ● - Non-unions and malunions . - Osteotomies and bone reconstruction t - Fractures in normal or osteoporotic bone 9
    Device Description
    The AngleFix T Locking Plate consists of plates to accommodate the patients' anatomy. Each plate has threaded holes and "finger holes" for the corresponding screws.
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