BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration

    K Number: K200376 · Decision Dec 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    2
    Review Days
    296

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    Basic Information

    Device Name
    Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration
    K Number
    K200376
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Navbit Pty, Ltd.
    Date Received
    February 18, 2020
    Decision Date
    December 10, 2020
    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 Navbit Pty, Ltd.

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