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

    HKT Anatomical Locking Trauma System

    K Number: K231213 · Decision Jan 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    2
    Review Days
    266

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    Basic Information

    Device Name
    HKT Anatomical Locking Trauma System
    K Number
    K231213
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hankil Tech Medical Co., Ltd.
    Date Received
    April 28, 2023
    Decision Date
    January 19, 2024
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Hankil Tech Medical Co., Ltd.

    K Number Device Name
    K254249 HKT Anatomical Locking Trauma System