BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SImmetry Sacroiliac Joint Fusion System

    K Number: K151818 · Decision Aug 5, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    121
    Applicant Total
    6
    Review Days
    30

    Basic Information

    Device Name
    SImmetry Sacroiliac Joint Fusion System
    K Number
    K151818
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zyga Technology, Inc.
    Date Received
    July 6, 2015
    Decision Date
    August 5, 2015
    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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