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

    ELEOS™ with NanoCept® Technology Limb Salvage System

    K Number: K253066 · Decision Jun 8, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    259

    Basic Information

    Device Name
    ELEOS™ with NanoCept® Technology Limb Salvage System
    K Number
    K253066
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3900
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Onkos Surgical, Inc.
    Date Received
    September 22, 2025
    Decision Date
    June 8, 2026
    Product Code
    QZZ
    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
    QZZ Limb And Joint Salvage Device With Coating For Bacteria Reduction

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    Other Clearances by Onkos Surgical, Inc.

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    K252920 ELEOS™ Limb Salvage System with NanoCept® Technology
    K223348 My3D® Personalized Pelvic Reconstruction
    K180130 ELEOS™ Bipolar Acetabular System
    K161520 ELEOS Limb Salvage System