Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K063461
    Device Name
    ANOVA CONTAINMENT DEVICE
    Manufacturer
    ANOVA CORPORATION
    Date Cleared
    2009-08-13

    (1002 days)

    Product Code
    EZX, KWO
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANOVA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anova Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
    Device Description
    The Anova Containment Device is a flexible, synthetic composite implantable mesh. It includes a polyester mesh component connected by a mono-filament suture to a porous expanded polytetrafluoroethylene or "ePTFE" component. This ePTFE component is placed between the polyester mesh and the overlying soft tissues. The ePTFE component is not anchored to the disc. The Anova Containment Device is attached to the spine with four suture anchors (two fastened to the vertebra above and two fastened to the vertebra below the disc). The sutures from the anchors overlay the mesh and hold it against the vertebral body and to reinforce the mesh against pressure from the graft material.
    Ask a Question

    Page 1 of 1