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

    OPERA CUPFLANGED ACETABULAR COMPONENTS

    K Number: K991538 · Decision Jun 3, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    10
    Review Days
    31

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    Basic Information

    Device Name
    OPERA CUPFLANGED ACETABULAR COMPONENTS
    K Number
    K991538
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew, Inc., Orthopaedic Div.
    Date Received
    May 3, 1999
    Decision Date
    June 3, 1999
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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