BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor

    K Number: K163672 · Decision May 5, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    8
    Review Days
    129

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    Basic Information

    Device Name
    Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor
    K Number
    K163672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanova Biomaterials, Inc.
    Date Received
    December 27, 2016
    Decision Date
    May 5, 2017
    Product Code
    MAI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MAI Fastener, Fixation, Biodegradable, Soft Tissue

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