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

    ELITE MODULAR HIP SYSTEM

    K Number: K871867 · Decision Apr 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    5
    Review Days
    331

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    Basic Information

    Device Name
    ELITE MODULAR HIP SYSTEM
    K Number
    K871867
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Thackray USA
    Date Received
    May 13, 1987
    Decision Date
    April 8, 1988
    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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    Other Clearances by Thackray USA

    K Number Device Name
    K882890 WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM
    K871852 COXA ACETABULAR CUP
    K863554 THACKRAY CRUCIATE SPARING KNEE CS-1
    K855166 THACKRAY TOTAL CONDYLAR KNEES