BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    VERTICALE® Triangular Fixation System

    K Number: K223806 · Decision Jul 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    12
    Review Days
    199

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    Basic Information

    Device Name
    VERTICALE® Triangular Fixation System
    K Number
    K223806
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Silony Medical GmbH
    Date Received
    December 19, 2022
    Decision Date
    July 6, 2023
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    Other Clearances by Silony Medical GmbH

    K Number Device Name
    K254148 VERTICALE GPS Instruments
    K223649 VERTICALE® Navigation Instruments
    K212007 VERTICALE Navigation Instruments
    K192013 VERTICALE® Cervical System
    K190680 FAVO S-TLIF
    K182608 Oyster ACIF Cage
    K181899 ROCCIA® PLIF
    K180963 ROCCIA ALIF, ROCCIA TLIF
    K171421 VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
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