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

    Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component

    K Number: K241716 · Decision Aug 2, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    30
    Review Days
    49

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    Basic Information

    Device Name
    Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
    K Number
    K241716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp., Dba Stryker Orthopaedics
    Date Received
    June 14, 2024
    Decision Date
    August 2, 2024
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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