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

    APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)

    K Number: K082468 · Decision Feb 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    216
    Registration Numbers
    216
    Same Product Code
    98
    Applicant Total
    21
    Review Days
    175

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    Basic Information

    Device Name
    APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)
    K Number
    K082468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3390
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omni Life Science, Inc.
    Date Received
    August 27, 2008
    Decision Date
    February 18, 2009
    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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