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

    ENOS Software Guided External Fixation System

    K Number: K253764 · Decision Feb 26, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    3
    Applicant Total
    6
    Review Days
    93

    Basic Information

    Device Name
    ENOS Software Guided External Fixation System
    K Number
    K253764
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Disior, Ltd.
    Date Received
    November 25, 2025
    Decision Date
    February 26, 2026
    Product Code
    OSN
    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
    OSN Software For Diagnosis/Treatment

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