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

    PIEZOSURGERY FLEX

    K Number: K132848 · Decision Nov 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    37
    Same Product Code
    22
    Applicant Total
    13
    Review Days
    79

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    Basic Information

    Device Name
    PIEZOSURGERY FLEX
    K Number
    K132848
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.4580
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mectron S.P.A.
    Date Received
    September 11, 2013
    Decision Date
    November 29, 2013
    Product Code
    JDX
    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
    JDX Instrument, Surgical, Sonic And Accessory/Attachment

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