BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    SIGNATURE PLANNER / SIGNATURE GUIDES

    K Number: K110415 · Decision May 16, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    90
    Applicant Total
    61
    Review Days
    91

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    Basic Information

    Device Name
    SIGNATURE PLANNER / SIGNATURE GUIDES
    K Number
    K110415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Materialise NV
    Date Received
    February 14, 2011
    Decision Date
    May 16, 2011
    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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