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

    ceramys™ femoral head system

    K Number: K241483 · Decision Feb 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    81
    Review Days
    259

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    Basic Information

    Device Name
    ceramys™ femoral head system
    K Number
    K241483
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Encore Medical L.P.
    Date Received
    May 24, 2024
    Decision Date
    February 7, 2025
    Product Code
    LZO
    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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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