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

    ELEOSx™ Limb Salvage System

    K Number: DEN210058 · Decision Apr 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    827

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    Basic Information

    Device Name
    ELEOSx™ Limb Salvage System
    K Number
    DEN210058
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    888.3900
    Medical Specialty
    Orthopedic
    Decision
    Unknown
    Applicant
    Onkos Surgical
    Date Received
    December 30, 2021
    Decision Date
    April 5, 2024
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QZZ), ordered by most recent decision date.

    ELEOS™ with NanoCept® Technology Limb Salvage System

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    ELEOS™ Limb Salvage System with NanoCept® Technology

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    Other Clearances by Onkos Surgical

    K Number Device Name
    K212815 My3D® Personalized Pelvic Reconstruction
    K211677 ELEOS Limb Salvage System
    K203815 ELEOS Limb Salvage System with BioGrip
    K203588 ELEOS™ Limb Salvage System
    K203090 ELEOS Limb Salvage System featuring BIOGRIP