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

    SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)

    K Number: K032108 · Decision Jan 15, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    207
    Review Days
    191

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    Basic Information

    Device Name
    SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
    K Number
    K032108
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap, Inc.
    Date Received
    July 8, 2003
    Decision Date
    January 15, 2004
    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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