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

    ACCIN UNI-KNEE SYSTEM

    K Number: K063782 · Decision Jan 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    113
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    ACCIN UNI-KNEE SYSTEM
    K Number
    K063782
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accin Corporation
    Date Received
    December 21, 2006
    Decision Date
    January 19, 2007
    Product Code
    HSX
    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
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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    Other Clearances by Accin Corporation

    K Number Device Name
    K060670 ACCIN UNI-KNEE SYSTEM