BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    PIEZOTOME M+, PIEZOTOME M+ Handpiece

    K Number: K163610 · Decision May 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    37
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    148

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    Basic Information

    Device Name
    PIEZOTOME M+, PIEZOTOME M+ Handpiece
    K Number
    K163610
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.4580
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Satalec-Acteon Group
    Date Received
    December 22, 2016
    Decision Date
    May 19, 2017
    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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