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

    Avanti Distal Radius and Forearm System

    K Number: K191118 · Decision Dec 13, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    3
    Review Days
    231

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    Basic Information

    Device Name
    Avanti Distal Radius and Forearm System
    K Number
    K191118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avanti Orthopaedics, Inc.
    Date Received
    April 26, 2019
    Decision Date
    December 13, 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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    Other Clearances by Avanti Orthopaedics, Inc.

    K Number Device Name
    K222967 Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
    K211592 Avanti Orthopaedics Ulnar Shortening System