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

    ELEOS Limb Salvage System

    K Number: K161520 · Decision Oct 28, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    5
    Review Days
    148

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    Basic Information

    Device Name
    ELEOS Limb Salvage System
    K Number
    K161520
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Onkos Surgical, Inc.
    Date Received
    June 2, 2016
    Decision Date
    October 28, 2016
    Product Code
    KRO
    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
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

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    Other Clearances by Onkos Surgical, Inc.

    K Number Device Name
    K253066 ELEOS™ with NanoCept® Technology Limb Salvage System
    K252920 ELEOS™ Limb Salvage System with NanoCept® Technology
    K223348 My3D® Personalized Pelvic Reconstruction
    K180130 ELEOS™ Bipolar Acetabular System