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510(k) Data Aggregation

    K Number
    K252087

    Validate with FDA (Live)

    Device Name
    Navigation Module of the Cortium® System
    Manufacturer
    Ulrich Medical USA, Inc.
    Date Cleared
    2026-02-03

    (216 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K230614,K200845,K143628,K170679
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Navigation Module of the Cortium® System is intended to be used during the preparation and placement of Cortium® Universal OCT Spinal Fixation System screws during spinal surgery, to assist the surgeon in precisely locating anatomical structures. The Navigation Module of the Cortium® System is designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks for the anatomy. Instruments of the Navigation Module of the Cortium® System are not intended for navigation of occipital screws.

    Device Description

    The Navigation Module of the Cortium® System contains non-sterile, reusable, manual surgical instruments including drills, taps, and screwdrivers. The instruments are manufactured from stainless steels which conform to ASTM F899. The instruments are designed for use with the Medtronic StealthStation surgical navigation system for implantation of the Cortium® Universal OCT Spinal Fixation System components. Instruments of the Navigation Module of the Cortium® System were tested for compatibility using StealthStation S8 software version 2.1.0.

    Instruments of the Navigation Module of the Cortium® System are not intended for navigation of occipital screws.

    AI/ML Overview

    N/A

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