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

    CL UNIVERSAL HIP DEVICE

    K Number: K885146 · Decision Apr 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    32
    Applicant Total
    8
    Review Days
    130

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    Basic Information

    Device Name
    CL UNIVERSAL HIP DEVICE
    K Number
    K885146
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3170
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Lima Intl. Corp.
    Date Received
    December 15, 1988
    Decision Date
    April 24, 1989
    Product Code
    KWI
    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
    KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

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    Other Clearances by Lima Intl. Corp.

    K Number Device Name
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    K896851 PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC
    K900051 MOORE TYPE ENDO PROSTHESIS
    K902621 SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT
    K896850 LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE
    K900257 MULLER TYPE ACETABULAR CUP