BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    FIXIT / ComposiTCP Threaded Anchor System

    K Number: K180960 · Decision Jul 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    1
    Review Days
    104

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    Basic Information

    Device Name
    FIXIT / ComposiTCP Threaded Anchor System
    K Number
    K180960
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S.B.M. Sas Sciences For Bio Materials
    Date Received
    April 12, 2018
    Decision Date
    July 25, 2018
    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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