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

    O-Genesis Graft Delivery System

    K Number: K200606 · Decision May 1, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    57
    Review Days
    53

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    Basic Information

    Device Name
    O-Genesis Graft Delivery System
    K Number
    K200606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthofix, Inc.
    Date Received
    March 9, 2020
    Decision Date
    May 1, 2020
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMF Syringe, Piston

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