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

    OPTI-FIX COLLARED FEMORAL COMPONENTS

    K Number: K874868 · Decision Jan 26, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    58
    Applicant Total
    71
    Review Days
    60

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    Basic Information

    Device Name
    OPTI-FIX COLLARED FEMORAL COMPONENTS
    K Number
    K874868
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Richards Medical Co., Inc.
    Date Received
    November 27, 1987
    Decision Date
    January 26, 1988
    Product Code
    JDG
    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
    JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

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    Other Clearances by Richards Medical Co., Inc.

    K Number Device Name
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    K884824 TRICON-M TOTAL KNEE SYSTEM
    K896204 ZIRCONIA CERAMIC HEAD ADD'L SIZES
    K895242 PAPPAS TRI-FLANGE VENTILATION TUBE
    K893377 RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
    K885069 ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
    K892366 POROUS GENESIS STEMMED TIBIAL COMPONENT
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