BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System

    K Number: K203671 · Decision Jan 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    130
    Applicant Total
    165
    Review Days
    28

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    Basic Information

    Device Name
    M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
    K Number
    K203671
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medacta International S.A.
    Date Received
    December 16, 2020
    Decision Date
    January 13, 2021
    Product Code
    OUR
    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
    OUR Sacroiliac Joint Fixation

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