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

    EVOS Small Fragment Upper Extremity Plates Line Additions

    K Number: K190253 · Decision Mar 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    505
    Registration Numbers
    505
    Same Product Code
    1254
    Applicant Total
    9
    Review Days
    32

    Basic Information

    Device Name
    EVOS Small Fragment Upper Extremity Plates Line Additions
    K Number
    K190253
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew, Inc
    Date Received
    February 7, 2019
    Decision Date
    March 11, 2019
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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