BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    FITBONE TAA

    K Number: K163368 · Decision Jan 26, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    295
    Registration Numbers
    295
    Same Product Code
    505
    Applicant Total
    2
    Review Days
    57

    Basic Information

    Device Name
    FITBONE TAA
    K Number
    K163368
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    WITTENSTEIN intens GmbH
    Date Received
    November 30, 2016
    Decision Date
    January 26, 2017
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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    Other Clearances by WITTENSTEIN intens GmbH

    K Number Device Name
    K203399 FITBONE(R) TAA