BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    SYPMHONY™ OCT System

    K Number: K192014 · Decision Jan 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    117
    Applicant Total
    96
    Review Days
    179

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    Basic Information

    Device Name
    SYPMHONY™ OCT System
    K Number
    K192014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3075
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medos International SARL
    Date Received
    July 29, 2019
    Decision Date
    January 24, 2020
    Product Code
    NKG
    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
    NKG Posterior Cervical Screw System

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