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

    P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT

    K Number: K900638 · Decision Apr 30, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    106
    Applicant Total
    10
    Review Days
    80

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    Basic Information

    Device Name
    P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT
    K Number
    K900638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Johnson & Johnson International
    Date Received
    February 9, 1990
    Decision Date
    April 30, 1990
    Product Code
    KWL
    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
    KWL Prosthesis, Hip, Hemi-, Femoral, Metal

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