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

    RMHS MONOLITHIC FEMORAL COMPONENT

    K Number: K931642 · Decision Apr 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    87
    Review Days
    392

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    Basic Information

    Device Name
    RMHS MONOLITHIC FEMORAL COMPONENT
    K Number
    K931642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Richards, Inc.
    Date Received
    April 2, 1993
    Decision Date
    April 29, 1994
    Product Code
    LPH
    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
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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    Other Clearances by Smith & Nephew Richards, Inc.

    K Number Device Name
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    K963509 GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
    K960444 FINN ROD TO ROD CONNECTOR
    K964163 TRIMAX NAIL SYSTEM
    K962557 GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
    K963486 REVISION HIP SYSTEM
    K962541 REFLECTION ACETABULAR REINFORCEMENT RINGS
    K962808 ILIZAROV EXTERNAL FIXATION SYSTEM
    K962137 GENESIS II CONSTRAINED SYSTEM
    K955767 COFIED MODULAR SHOULDER SYSTEM
    Search all 87 clearances from Smith & Nephew Richards, Inc. →