BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    INTRAFIX(TM) Advance Tibial Fastener System

    K Number: K160804 · Decision Jul 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    96
    Review Days
    118

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    Basic Information

    Device Name
    INTRAFIX(TM) Advance Tibial Fastener System
    K Number
    K160804
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medos International SARL
    Date Received
    March 23, 2016
    Decision Date
    July 19, 2016
    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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