BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Estremo Citieffe Nailing System

    K Number: K181540 · Decision Jan 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    295
    Registration Numbers
    295
    Same Product Code
    505
    Applicant Total
    1
    Review Days
    219

    Basic Information

    Device Name
    Estremo Citieffe Nailing System
    K Number
    K181540
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    CITIEFFE S.r.L.
    Date Received
    June 11, 2018
    Decision Date
    January 16, 2019
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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