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

    MODIFICATION TO:SBI RINGFIX

    K Number: K071394 · Decision Jun 29, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    20
    Review Days
    39

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    Basic Information

    Device Name
    MODIFICATION TO:SBI RINGFIX
    K Number
    K071394
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Small Bone Innovations, Inc.
    Date Received
    May 21, 2007
    Decision Date
    June 29, 2007
    Product Code
    KTT
    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
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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    Other Clearances by Small Bone Innovations, Inc.

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