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

    BALTEUM - ONE™ Lumbar Plate System

    K Number: K213820 · Decision Mar 25, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    8
    Review Days
    107

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    Basic Information

    Device Name
    BALTEUM - ONE™ Lumbar Plate System
    K Number
    K213820
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Huvexel Co. , Ltd.
    Date Received
    December 8, 2021
    Decision Date
    March 25, 2022
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

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