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

    Tesera-k PL System and Tesera-k XL System

    K Number: K242771 · Decision Mar 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    15
    Review Days
    188

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    Basic Information

    Device Name
    Tesera-k PL System and Tesera-k XL System
    K Number
    K242771
    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 13, 2024
    Decision Date
    March 20, 2025
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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