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

    NBX - NON-BRIDGING EXTERNAL FIXATOR

    K Number: K020905 · Decision Apr 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    56
    Applicant Total
    34
    Review Days
    26

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    Basic Information

    Device Name
    NBX - NON-BRIDGING EXTERNAL FIXATOR
    K Number
    K020905
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Orthopedics, Inc.
    Date Received
    March 20, 2002
    Decision Date
    April 15, 2002
    Product Code
    LXT
    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
    LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

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