# VUZE System

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/vuze-system-llz-k210830>
- Manufacturer: [Vuze Medical Ltd](https://devicerts.com/manufacturers/vuze-medical-ltd) (Israel, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: LLZ

## Overview

*AI-generated summary, 2026-10-06. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The VUZE System is a software-based surgical guidance system designed to assist during spine surgeries performed manually on short spinal segments. It operates as a software-only complement to traditional hardware-based navigation, providing guidance using standard 2D X-ray imaging and a PC. The system is designed to work with unmodified surgical tools without requiring tool add-ons, cameras, markers, or external references.

The system is primarily aimed for use in outpatient and ambulatory surgical settings. It received initial U.S. FDA 510(k) clearance in 2022 under submission number K210830.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K210830 · decision 2022-01-03 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K210830 [FDA 510(k)]
- FDA product code: LLZ [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.2050 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: VUZE System, Vuze Medical Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/vuze-system-llz-k210830 (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/vuze-system-llz-k210830.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/vuze-system-llz-k210830
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.