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

    Trigon™ HA Stand-Alone Wedge Fixation System

    K Number: K223226 · Decision Dec 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    17
    Applicant Total
    24
    Review Days
    44

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    Basic Information

    Device Name
    Trigon™ HA Stand-Alone Wedge Fixation System
    K Number
    K223226
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nvision Biomedical Technologies, Inc.
    Date Received
    October 18, 2022
    Decision Date
    December 1, 2022
    Product Code
    PLF
    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
    PLF Bone Wedge

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