BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    UNITY Sacroiliac Joint Fixation System

    K Number: K173201 · Decision Apr 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    130
    Applicant Total
    8
    Review Days
    206

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    Basic Information

    Device Name
    UNITY Sacroiliac Joint Fixation System
    K Number
    K173201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Huvexel Co. , Ltd.
    Date Received
    October 2, 2017
    Decision Date
    April 26, 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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