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

    SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides

    K Number: K163156 · Decision Jan 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    26
    Applicant Total
    61
    Review Days
    69

    Basic Information

    Device Name
    SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides
    K Number
    K163156
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Materialise NV
    Date Received
    November 10, 2016
    Decision Date
    January 18, 2017
    Product Code
    PBF
    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
    PBF Orthopaedic Surgical Planning And Instrument Guides

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