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

    AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000

    K Number: K981423 · Decision May 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    84
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
    K Number
    K981423
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Autogenesis, Inc.
    Date Received
    April 20, 1998
    Decision Date
    May 20, 1998
    Product Code
    JEC
    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
    JEC Component, Traction, Invasive

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    Other Clearances by Autogenesis, Inc.

    K Number Device Name
    K013818 AUTOGENESIS AUTOMATOR, MODEL M1000