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

    STEALTH FUSION SYSTEM, MODEL RR 1000

    K Number: K043174 · Decision Feb 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    2
    Review Days
    83

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    Basic Information

    Device Name
    STEALTH FUSION SYSTEM, MODEL RR 1000
    K Number
    K043174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R&R Medical, Inc.
    Date Received
    November 16, 2004
    Decision Date
    February 7, 2005
    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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