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

    TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM

    K Number: K970748 · Decision May 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    247
    Registration Numbers
    247
    Same Product Code
    392
    Applicant Total
    10
    Review Days
    67

    Basic Information

    Device Name
    TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM
    K Number
    K970748
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
    Date Received
    March 3, 1997
    Decision Date
    May 9, 1997
    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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