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

    KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System

    K Number: K193320 · Decision Feb 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    15
    Review Days
    64

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    Basic Information

    Device Name
    KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
    K Number
    K193320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kyocera Medical Technologies, Inc.
    Date Received
    December 2, 2019
    Decision Date
    February 4, 2020
    Product Code
    OVD
    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
    OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

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    Other Clearances by Kyocera Medical Technologies, Inc.

    K Number Device Name
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    K232114 TRIBRID® Unicompartmental Knee System
    K230808 PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
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