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

    REVISION HIP SYSTEM

    K Number: K963486 · Decision Nov 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    87
    Review Days
    85

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    Basic Information

    Device Name
    REVISION HIP SYSTEM
    K Number
    K963486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Richards, Inc.
    Date Received
    September 3, 1996
    Decision Date
    November 27, 1996
    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 Smith & Nephew Richards, Inc.

    K Number Device Name
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    K960444 FINN ROD TO ROD CONNECTOR
    K964163 TRIMAX NAIL SYSTEM
    K962557 GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
    K962541 REFLECTION ACETABULAR REINFORCEMENT RINGS
    K962808 ILIZAROV EXTERNAL FIXATION SYSTEM
    K962137 GENESIS II CONSTRAINED SYSTEM
    K955767 COFIED MODULAR SHOULDER SYSTEM
    K960094 REFLECTION DUAL DIMENSION SHELL
    Search all 87 clearances from Smith & Nephew Richards, Inc. →