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

    LEGION Total Knee System

    K Number: K250677 · Decision Apr 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    320
    Registration Numbers
    320
    Same Product Code
    902
    Applicant Total
    83
    Review Days
    27

    Basic Information

    Device Name
    LEGION Total Knee System
    K Number
    K250677
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew, Inc.
    Date Received
    March 6, 2025
    Decision Date
    April 2, 2025
    Product Code
    JWH
    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
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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