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

    UNI KNEE

    K Number: K022437 · Decision Aug 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    90
    Applicant Total
    52
    Review Days
    29

    Basic Information

    Device Name
    UNI KNEE
    K Number
    K022437
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ENCORE MEDICAL, L.P.
    Date Received
    July 25, 2002
    Decision Date
    August 23, 2002
    Product Code
    HRY
    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
    HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

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