Manufacturer
Curexo, Inc.CUVIS-spine
Country / Region:Korea, Republic of (KR)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
- K223558
- Device name
- CUVIS-spine
- Company
- Curexo, Inc.
- Country / Region
- Korea, Republic of(KR)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2022-11-28
- Decision date
- 2023-06-22
- 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
CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous pedicle screw placement provided that the required markers and rigid patient anatomy can be identified on 3D or 2D image.
Intended Use
CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous pedicle screw placement provided that the required markers and rigid patient anatomy can be identified on 3D or 2D image.
Device Description
The CUVIS-spine is a mobile system mainly comprising the robotic arm, the main console and the staff console as an option. The robotic arm is positioned on the floor near the side of the surgical table. The location of the main console or the staff console is appropriately determined considering the user preference and the environments. The CUVIS-spine is a mobile system mainly comprising the robotic arm, the main console and the staff console as an option. The robotic arm is positioned on the floor near the side of the surgical table. The location of the main console or the staff console is appropriately determined considering the user preference and the environments. The EXCELSIUS GPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), using a dynamic reference base and positioning camera.
Summary parsed at:2026-06-19 05:42:06 UTC
