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

    IXOS Radius Plate System

    K Number: K171624 · Decision Mar 29, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    3
    Review Days
    300

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    Basic Information

    Device Name
    IXOS Radius Plate System
    K Number
    K171624
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stuckenbrock Medizintechnik GmbH
    Date Received
    June 2, 2017
    Decision Date
    March 29, 2018
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Stuckenbrock Medizintechnik GmbH

    K Number Device Name
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    K042902 HERBERT ULNAR HEAD PROSTHESIS SYSTEM