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

    DeGen Navigated Instrumentation

    K Number: K203816 · Decision Apr 2, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    370
    Registration Numbers
    370
    Same Product Code
    404
    Applicant Total
    9
    Review Days
    94

    Basic Information

    Device Name
    DeGen Navigated Instrumentation
    K Number
    K203816
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DeGen Medical
    Date Received
    December 29, 2020
    Decision Date
    April 2, 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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