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

    Zimmer Biomet Ceramic Heads (22.2mm diameter)

    K Number: K250834 · Decision Apr 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    Zimmer Biomet Ceramic Heads (22.2mm diameter)
    K Number
    K250834
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Biomet
    Date Received
    March 19, 2025
    Decision Date
    April 18, 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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