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

    Foot and Ankle System

    K Number: K200062 · Decision Feb 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    1
    Review Days
    406

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    Basic Information

    Device Name
    Foot and Ankle System
    K Number
    K200062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Leith Medical, LLC
    Date Received
    January 13, 2020
    Decision Date
    February 22, 2021
    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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