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CUVIS-spine

Curexo, Inc.

Country / Region:Korea, Republic of (KR)Submission type:Special

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Korea, Republic of (KR)

Product code

OLO
21 CFR 882.4560

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K222698
Device name
CUVIS-spine
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

Predicate devices

2

K222698 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K222698 as a predicate