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510(k) Data Aggregation

    K Number
    K133021
    Device Name
    MIXING SYRINGE SYSTEM
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Date Cleared
    2014-01-13

    (109 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZIMMER KNEE CREATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mixing Syringe System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
    Device Description
    The Mixing Syringe System is comprised of a commercially available disposable medical piston syringe (syringe barrel with female luer, plunger), and mixing system funnel. The Mixing Syringe System is provided sterile, for single use only.
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