BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II

    K Number: K251315 · Decision May 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    370
    Registration Numbers
    370
    Same Product Code
    404
    Applicant Total
    5
    Review Days
    30

    Basic Information

    Device Name
    Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
    K Number
    K251315
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Remex Medical Corp.
    Date Received
    April 29, 2025
    Decision Date
    May 29, 2025
    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 Remex Medical Corp.

    K Number Device Name
    K243560 Remex Spine Surgery Navigation Instrument
    K241625 Anatase Navi Disposable Instrument
    K233513 Remex Spine Surgery Navigation System II
    K230783 Anatase Spine Surgery Navigation System