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

    VERTICALE Navigation Instruments

    K Number: K212007 · Decision Aug 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    12
    Review Days
    45

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    Basic Information

    Device Name
    VERTICALE Navigation Instruments
    K Number
    K212007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Silony Medical GmbH
    Date Received
    June 28, 2021
    Decision Date
    August 12, 2021
    Product Code
    OLO
    Advisory Committee
    Neurology
    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
    OLO Orthopedic Stereotaxic Instrument

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    Other Clearances by Silony Medical GmbH

    K Number Device Name
    K254148 VERTICALE GPS Instruments
    K223806 VERTICALE® Triangular Fixation System
    K223649 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
    K171434 ROCCIA® MultiLIF
    Search all 12 clearances from Silony Medical GmbH →