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

    SI Screw System

    K Number: K173752 · Decision Mar 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    130
    Applicant Total
    30
    Review Days
    98

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    Basic Information

    Device Name
    SI Screw System
    K Number
    K173752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zavation Medical Products, LLC
    Date Received
    December 8, 2017
    Decision Date
    March 16, 2018
    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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