# K223558: CUVIS-spine

- Pathway: 510(k) (Traditional)
- Applicant: Curexo, Inc.
- Decided: Jun 22, 2023 after 206 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K040583 (2004). 428 ancestors in all.
No later device cites it as a predicate yet.
1 of 429 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201569: CUVIS-spine, Curexo, Inc. (2021) Summary page 5.
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K223558
Methodology: https://510kreport.com/methodology