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

    STRYKER COMPARTMENTAL KNEE SYSTEM

    K Number: K052917 · Decision Dec 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    11
    Applicant Total
    288
    Review Days
    71

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    Basic Information

    Device Name
    STRYKER COMPARTMENTAL KNEE SYSTEM
    K Number
    K052917
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp.
    Date Received
    October 17, 2005
    Decision Date
    December 27, 2005
    Product Code
    NPJ
    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
    NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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