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

    GENESYS PRESSFT SUTURE ANCHOR

    K Number: K121890 · Decision Aug 22, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    4
    Review Days
    55

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    Basic Information

    Device Name
    GENESYS PRESSFT SUTURE ANCHOR
    K Number
    K121890
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Linvatec Corporation D/B/A Conmed Linvatec
    Date Received
    June 28, 2012
    Decision Date
    August 22, 2012
    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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    Other Clearances by Linvatec Corporation D/B/A Conmed Linvatec

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    K130497 D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION
    K112965 NANO SUTURE ANCHOR