Manufacturer
Curexo, Inc.CUVIS-spine
Country / Region:Korea, Republic of (KR)Submission type:Special
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
- K222698
- 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
- 2022-09-07
- Decision date
- 2022-10-07
- Submission type
- Special
- Technology type
- Software Navigation(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 surgical procedures if the required markers and rigid patient anatomy can be identified on O-arm or C-arm.
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 surgical procedures if the required markers and rigid patient anatomy can be identified on O-arm or C-arm.
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. CUVIS-spine is a pedicle screw guide system which consists of Robotic Arm, Main Console, Staff Console, Guide bush, Source Calibrator, Registration Tool, Registration Tool Adapter, Robotic Arm Drape, Tool Drape, Detector Drape, Marker Ball, Patient Marker, Marker Driver, Detector Calibrator, Dilator, Serration-tip Dilator, Drill Bit, Tapper, Stylet Tapper, Screwdriver, Instrument Container.
Summary parsed at:2026-06-24 04:36:49 UTC
