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

    EQUATOR PLUS ACETABULAR CUP SYSTEM

    K Number: K051844 · Decision Oct 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    92

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    Basic Information

    Device Name
    EQUATOR PLUS ACETABULAR CUP SYSTEM
    K Number
    K051844
    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
    July 7, 2005
    Decision Date
    October 7, 2005
    Product Code
    MAY
    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
    MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

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