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

    PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD

    K Number: K061564 · Decision Sep 1, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    5
    Review Days
    88

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    Basic Information

    Device Name
    PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
    K Number
    K061564
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Portland Orthopaedics Pty. , Ltd.
    Date Received
    June 5, 2006
    Decision Date
    September 1, 2006
    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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    Other Clearances by Portland Orthopaedics Pty. , Ltd.

    K Number Device Name
    K053417 M-COR HIP REPLACEMENT SYSTEM
    K051844 EQUATOR PLUS ACETABULAR CUP SYSTEM
    K032641 MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
    K992815 THE MARGRON HIP REPLACEMENT SYSTEM