BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM

    K Number: K130146 · Decision May 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    107
    Applicant Total
    5
    Review Days
    118

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    Basic Information

    Device Name
    SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
    K Number
    K130146
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (Usa), LLC
    Date Received
    January 22, 2013
    Decision Date
    May 20, 2013
    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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