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

    MOORE TYPE ENDO PROSTHESIS

    K Number: K900051 · Decision Oct 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    216
    Registration Numbers
    216
    Same Product Code
    98
    Applicant Total
    8
    Review Days
    273

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    Basic Information

    Device Name
    MOORE TYPE ENDO PROSTHESIS
    K Number
    K900051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3390
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Lima Intl. Corp.
    Date Received
    January 3, 1990
    Decision Date
    October 3, 1990
    Product Code
    KWY
    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
    KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

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    Other Clearances by Lima Intl. Corp.

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    K902621 SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT
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    K885146 CL UNIVERSAL HIP DEVICE