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

    FaSet Fixation System

    K Number: K180729 · Decision Jun 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    77
    Applicant Total
    8
    Review Days
    100

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    Basic Information

    Device Name
    FaSet Fixation System
    K Number
    K180729
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Huvexel Co. , Ltd.
    Date Received
    March 20, 2018
    Decision Date
    June 28, 2018
    Product Code
    MRW
    Advisory Committee
    Unknown
    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
    MRW System, Facet Screw Spinal Device

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