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510(k) Data Aggregation

    K Number
    K093551
    Device Name
    PARADIS VASO SHIELD
    Manufacturer
    SPINEMEDICA, LLC
    Date Cleared
    2009-12-24

    (37 days)

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

    SPINEMEDICA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpineMedica Paradis Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.
    Device Description
    The SpineMedica Paradis Vaso Shield™ is a flexible sheet of 30 Wt.1% polyvinyl alcohol (PVA) material with dimensions of 60 ±6 mm X 100 ±10 mm and a thickness of 1.0 ±0.2 mm. The corners of the sheet are rounded. 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 in saline solution.
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    K Number
    K090022
    Device Name
    PARADIS VASO SHIELD
    Manufacturer
    SPINEMEDICA, LLC
    Date Cleared
    2009-04-20

    (105 days)

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

    SPINEMEDICA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpineMedica Paradís Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.
    Device Description
    The SpineMedica Paradís Vaso Shield™ is a flexible sheet of 30 Wt.% polyvinyl alcohol (PVA) material with dimensions of 60 ±6 mm X 100 ±10 mm and a thickness of 1.0 ±0.2 mm. The corners of the sheet are rounded. 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 in saline solution.
    Ask a Question

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