Manufacturer
Ulrich Medical USA, Inc.Navigation Module of the Cortium® System
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K252087
- Device name
- Navigation Module of the Cortium® System
- Company
- Ulrich Medical USA, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-07-02
- Decision date
- 2026-02-03
- Submission type
- Traditional
- Technology type
- Image Guided Surgery(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for 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.
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.
Summary parsed at:2026-06-19 04:30:06 UTC