BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    xvision Spine system

    K Number: K251639 · Decision Oct 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    41
    Applicant Total
    6
    Review Days
    127

    Basic Information

    Device Name
    xvision Spine system
    K Number
    K251639
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Augmedics, Ltd.
    Date Received
    May 29, 2025
    Decision Date
    October 3, 2025
    Product Code
    SBF
    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
    SBF Orthopedic Augmented Reality

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    Other Clearances by Augmedics, Ltd.

    K Number Device Name
    K250255 xvision Spine system
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    K190929 xvision Spine system (XVS)