BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters

    K Number: K152557 · Decision Feb 23, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    107
    Applicant Total
    12
    Review Days
    168

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    Basic Information

    Device Name
    Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
    K Number
    K152557
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    G21, S.R.L.
    Date Received
    September 8, 2015
    Decision Date
    February 23, 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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