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

    TRACKER Plus Kyphoplasty System

    K Number: K211797 · Decision Oct 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    107
    Applicant Total
    18
    Review Days
    140

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    Basic Information

    Device Name
    TRACKER Plus Kyphoplasty System
    K Number
    K211797
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GS Medical Co., Ltd.
    Date Received
    June 10, 2021
    Decision Date
    October 28, 2021
    Product Code
    NDN
    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
    NDN Cement, Bone, Vertebroplasty

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