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

    EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM

    K Number: K092143 · Decision Sep 22, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    158
    Applicant Total
    22
    Review Days
    69

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    Basic Information

    Device Name
    EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
    K Number
    K092143
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap Implant Systems, Inc.
    Date Received
    July 15, 2009
    Decision Date
    September 22, 2009
    Product Code
    MEH
    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
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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