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

    MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides

    K Number: K220888 · Decision May 24, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    165
    Review Days
    57

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    Basic Information

    Device Name
    MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
    K Number
    K220888
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medacta International S.A.
    Date Received
    March 28, 2022
    Decision Date
    May 24, 2022
    Product Code
    QSR
    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
    QSR Sacroiliac Screw Placement Guide

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