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

    NANO SUTURE ANCHOR

    K Number: K112965 · Decision Nov 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    564
    Applicant Total
    4
    Review Days
    28

    Basic Information

    Device Name
    NANO SUTURE ANCHOR
    K Number
    K112965
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LINVATEC CORPORATION D/B/A CONMED LINVATEC
    Date Received
    October 5, 2011
    Decision Date
    November 2, 2011
    Product Code
    MBI
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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    Other Clearances by LINVATEC CORPORATION D/B/A CONMED LINVATEC

    K Number Device Name
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    K130497 D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION
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