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510(k) Data Aggregation

    K Number
    K083458
    Device Name
    INTRAMEDULLARY FIXATION ROD (IFS)
    Manufacturer
    NOVALIGN ORTHOPAEDICS, INC
    Date Cleared
    2009-02-09

    (80 days)

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

    NOVALIGN ORTHOPAEDICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NovaLign™ Intramedullary Fixation System is intended for use in the fixation of long bone fractures, including fractures in the humerus, femur and the tibia.
    Device Description
    The NovaLign™ Intramedullary Fixation System is a segmented, intramedullary nail intended for long bone fracture fixation. The device is intended to function as a flexible intramedullary nail during device placement, but will be made rigid at the completion of the surgical implantation procedure.
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