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

    MEDINAUT Kyphoplasty System

    K Number: K153296 · Decision Jul 29, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    107
    Applicant Total
    6
    Review Days
    259

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    Basic Information

    Device Name
    MEDINAUT Kyphoplasty System
    K Number
    K153296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imedicom Co., Ltd.
    Date Received
    November 13, 2015
    Decision Date
    July 29, 2016
    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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    Other Clearances by Imedicom Co., Ltd.

    K Number Device Name
    K182287 MEDINAUT Plus
    K173541 EPINAUT
    K150915 SPINAUT-P
    K151268 SPINAUT-V, SPINAUT-S, SPINAUT-I
    K150789 SPINAUT-E, SPINAUT-I