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

    APEX MODULAR ALUMINA FEMORAL HEAD

    K Number: K012918 · Decision Nov 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    6
    Review Days
    89

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    Basic Information

    Device Name
    APEX MODULAR ALUMINA FEMORAL HEAD
    K Number
    K012918
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apex Surgical, LLC
    Date Received
    August 30, 2001
    Decision Date
    November 27, 2001
    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 Apex Surgical, LLC

    K Number Device Name
    K043123 APEX MODULAR HA HIP STEM
    K041950 APEX K2 HIP SYSTEM
    K031110 APEX MODULAR ACETABULAR CUP
    K003923 APEX MODULAR ZIRCONIA FEMORAL HEAD
    K000788 APEX MODULAR HIP STEM