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

    XO1 Knee Balancing System

    K Number: K162237 · Decision Apr 25, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    259

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    Basic Information

    Device Name
    XO1 Knee Balancing System
    K Number
    K162237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Xpandortho, Inc.
    Date Received
    August 9, 2016
    Decision Date
    April 25, 2017
    Product Code
    ONN
    Advisory Committee
    Neurology
    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
    ONN Intraoperative Orthopedic Joint Assessment Aid

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