BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Allure Hip Stem and Intramedullary Plugs

    K Number: K250375 · Decision Nov 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    158
    Applicant Total
    42
    Review Days
    268

    Basic Information

    Device Name
    Allure Hip Stem and Intramedullary Plugs
    K Number
    K250375
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Waldemar Link GmbH & Co. KG
    Date Received
    February 10, 2025
    Decision Date
    November 5, 2025
    Product Code
    MEH
    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
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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