BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    Dynamis Robotic Surgical System

    K Number: K260369 · Decision Jun 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    2
    Review Days
    135

    Basic Information

    Device Name
    Dynamis Robotic Surgical System
    K Number
    K260369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LEM Surgical AG
    Date Received
    February 5, 2026
    Decision Date
    June 20, 2026
    Product Code
    OLO
    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
    OLO Orthopedic Stereotaxic Instrument

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    Other Clearances by LEM Surgical AG

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    K243326 Dynamis Robotic Surgical System