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510(k) Data Aggregation

    K Number
    K133104
    Device Name
    VAN HIP FRACTURE SYSTEM
    Date Cleared
    2014-03-10

    (161 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIX ORTHOPAEDIC, CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VAN Hip Fracture System is indicated for fixation of fractures of the femur, including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures and combinations of these fractures, pathological fractures in both diaphyseal and trochanteric areas, and nonunion or malunion.
    Device Description
    The VAN Hip Fracture System includes short and long intramedullary nails, lag screws and distal locking cortical bone screws. The nail contains an angle adjust feature that allows for the neck/shaft angle to be adjusted to accommodate anatomical variations in the femoral neck angle.
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