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

    SpineKure Kyphoplasty System

    K Number: K172871 · Decision May 29, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    107
    Applicant Total
    1
    Review Days
    250

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    Basic Information

    Device Name
    SpineKure Kyphoplasty System
    K Number
    K172871
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hanchang Co., Ltd.
    Date Received
    September 21, 2017
    Decision Date
    May 29, 2018
    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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