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    K Number
    K161174
    Device Name
    Nanova Interference Screw
    Manufacturer
    NANOVA BIOMATERIALS INC.
    Date Cleared
    2016-11-03

    (191 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    NANOVA BIOMATERIALS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nanova™ Interference Screw is indicated for the fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee. The 7, 8 and 9mm x 23mm screws are also indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.
    Device Description
    Nanova™ Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of soft tissue grafts or bone-tendon-bone grafts. The device is made from a copolymer of absorbable Poly-L/D-lactide (PLDLA) reinforced with hydroxyapatite. Nanova™ Interference Screws are single use, prescription, long term implant, no drug.
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