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510(k) Data Aggregation

    K Number
    K111137
    Device Name
    HYDROFIX VASO SHIELD
    Manufacturer
    MIMEDX GROUP INC
    Date Cleared
    2011-05-20

    (28 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIMEDX GROUP INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiMedx HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery. Fusion surgery, Adjacent level surgery, Artificial Disc Implantation, Implant or Hardware Removal, Trauma, Vascular Surgery in the Spine.
    Device Description
    The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. It is slippery, clear, pliable, conformable, nanoporous permanent vessel cover that minimizes tissue contact between the vessels and the spine. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.
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