BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    ROSA ONE Spine application

    K Number: K192173 · Decision Oct 29, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    8
    Review Days
    78

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    Basic Information

    Device Name
    ROSA ONE Spine application
    K Number
    K192173
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtech S.A
    Date Received
    August 12, 2019
    Decision Date
    October 29, 2019
    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 Medtech S.A

    K Number Device Name
    K200511 ROSA ONE Brain application
    K182848 ROSA ONE Spine application
    K182417 ROSA ONE Brain Application
    K172444 ROSA BRAIN (v3.0.0.5)
    K151511 ROSA Spine
    K151359 ROSA Brain
    K092239 ROSA SURGICAL DEVICE, MODEL ROSA 1.1