Manufacturer
Providence Medical Technology, Inc.CORUS™ Navigation System-GX
Providence Medical Technology, Inc.
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
- K251060
- Device name
- CORUS™ Navigation System-GX
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-04-04
- Decision date
- 2025-07-30
- Submission type
- Traditional
- Technology type
- Software Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
The CORUS™ Navigation System-GX for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUS™ Navigation System-GX is specifically designed for use with the Globus Medical ExcelsiusGPS™ which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.
Intended Use
The CORUS™ Navigation System-GX for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUS™ Navigation System-GX is specifically designed for use with the Globus Medical ExcelsiusGPS™ which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.
Device Description
The CORUS™ Navigation System-GX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel-G and Navigation Chisel Rasp-G are specifically designed for use with Globus Medical ExcelsiusGPS™ for navigation of the instruments to the facet joint. The instrument set provides access to the posterior spinal facet joint and decortication for bone preparation.
Summary parsed at:2026-06-19 05:22:03 UTC
Predicate devices
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CORUS Navigation Access System
K251060 references 4 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251060 as a predicate