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

    ELEOS™ Limb Salvage System

    K Number: K203588 · Decision Feb 5, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    6
    Review Days
    59

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    Basic Information

    Device Name
    ELEOS™ Limb Salvage System
    K Number
    K203588
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Onkos Surgical
    Date Received
    December 8, 2020
    Decision Date
    February 5, 2021
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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    Other Clearances by Onkos Surgical

    K Number Device Name
    DEN210058 ELEOSx™ Limb Salvage System
    K212815 My3D® Personalized Pelvic Reconstruction
    K211677 ELEOS Limb Salvage System
    K203815 ELEOS Limb Salvage System with BioGrip
    K203090 ELEOS Limb Salvage System featuring BIOGRIP