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

    APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]

    K Number: K080842 · Decision May 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    21
    Review Days
    59

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    Basic Information

    Device Name
    APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]
    K Number
    K080842
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omni Life Science, Inc.
    Date Received
    March 25, 2008
    Decision Date
    May 23, 2008
    Product Code
    MBH
    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
    MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

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    Other Clearances by Omni Life Science, Inc.

    K Number Device Name
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    K112891 APEX REVISION KNEE SYSTEMS
    K113242 APEX ARC HIP STEM
    K111062 APEX KNEE SYSTEM, APEX ALL POLY TIBIA
    K111193 APEX ARC HIP STEM
    K111184 APEX PS KNEE SYSTEM - PS-C INSERT
    K110947 APEX K1 HIP STEM
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