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

    Optetrak Advanced Patella

    K Number: K160484 · Decision Mar 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    320
    Registration Numbers
    320
    Same Product Code
    902
    Applicant Total
    6
    Review Days
    25

    Basic Information

    Device Name
    Optetrak Advanced Patella
    K Number
    K160484
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    EXACTECH INC
    Date Received
    February 22, 2016
    Decision Date
    March 18, 2016
    Product Code
    JWH
    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
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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