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

    LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE

    K Number: K896850 · Decision Jun 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    8
    Review Days
    182

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    Basic Information

    Device Name
    LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE
    K Number
    K896850
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Lima Intl. Corp.
    Date Received
    December 5, 1989
    Decision Date
    June 5, 1990
    Product Code
    LZO
    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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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    Other Clearances by Lima Intl. Corp.

    K Number Device Name
    K922613 CL HIP STEM H/A COATED
    K910836 LIMA COLLARED CL STEM
    K896851 PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC
    K900051 MOORE TYPE ENDO PROSTHESIS
    K902621 SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT
    K900257 MULLER TYPE ACETABULAR CUP
    K885146 CL UNIVERSAL HIP DEVICE