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

    MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION

    K Number: K080885 · Decision Apr 28, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    165
    Review Days
    28

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    Basic Information

    Device Name
    MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION
    K Number
    K080885
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medacta International S.A.
    Date Received
    March 31, 2008
    Decision Date
    April 28, 2008
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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