BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    ARIX Ankle Distal Tibia System

    K Number: K202912 · Decision Oct 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    505
    Registration Numbers
    505
    Same Product Code
    1254
    Applicant Total
    33
    Review Days
    30

    Basic Information

    Device Name
    ARIX Ankle Distal Tibia System
    K Number
    K202912
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jeil Medical Corporation
    Date Received
    September 29, 2020
    Decision Date
    October 29, 2020
    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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