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

    Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts

    K Number: K152169 · Decision Oct 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    910
    Applicant Total
    14
    Review Days
    84

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    Basic Information

    Device Name
    Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts
    K Number
    K152169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho Development Corporation
    Date Received
    August 4, 2015
    Decision Date
    October 27, 2015
    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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