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

    LIMA COLLARED CL STEM

    K Number: K910836 · Decision Jun 14, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    8
    Review Days
    107

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    Basic Information

    Device Name
    LIMA COLLARED CL STEM
    K Number
    K910836
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Lima Intl. Corp.
    Date Received
    February 27, 1991
    Decision Date
    June 14, 1991
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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    Other Clearances by Lima Intl. Corp.

    K Number Device Name
    K922613 CL HIP STEM H/A COATED
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    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
    K885146 CL UNIVERSAL HIP DEVICE