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

    XD880A Ultrasonic Osteotomy Surgical System

    K Number: K172464 · Decision Apr 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    37
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    253

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    Basic Information

    Device Name
    XD880A Ultrasonic Osteotomy Surgical System
    K Number
    K172464
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.4580
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Morley Research Consortium
    Date Received
    August 14, 2017
    Decision Date
    April 24, 2018
    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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