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

    Smith and Nephew Legion Hinge Knee System

    K Number: K151118 · Decision Jul 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    16
    Review Days
    92

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    Basic Information

    Device Name
    Smith and Nephew Legion Hinge Knee System
    K Number
    K151118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew
    Date Received
    April 27, 2015
    Decision Date
    July 28, 2015
    Product Code
    KRO
    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
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

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