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

    Tesera-K SC System

    K Number: K223105 · Decision Dec 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    161
    Applicant Total
    15
    Review Days
    83

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    Basic Information

    Device Name
    Tesera-K SC System
    K Number
    K223105
    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
    September 30, 2022
    Decision Date
    December 22, 2022
    Product Code
    OVE
    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
    OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

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    Other Clearances by Kyocera Medical Technologies, Inc.

    K Number Device Name
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    K230808 PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
    K212980 Tesera-k ALIF System
    K212070 KMTI S141 Lumbar Interbody Fusion System
    K203472 KMTI Hip Replacement System
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