# X-Guide Surgical Navigation System

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

- Canonical page: <https://devicerts.com/devices/x-guide-surgical-navigation-system-plv>
- Manufacturer: [X-Nav Technologies, LLC](https://devicerts.com/manufacturers/x-nav-technologies-llc) (United States)
- Device class: Class II (US FDA)
- FDA product code: PLV

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K150222 · decision 2015-10-08 · decision SESE · status: Active

## Recalls

- Z-1391-2016 · Class II · terminated · initiated 2016-02-23: The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures. The X-Clip contains three fiducial markers made from a Stainless Steel material. The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3

## Identifiers

- 510(k) Number: K150222 [FDA 510(k)]
- FDA product code: PLV [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 872.4120 [FDA 510(k)]
- Advisory committee: Dental [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: X-Guide Surgical Navigation System, X-Nav Technologies, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/x-guide-surgical-navigation-system-plv (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-10
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/x-guide-surgical-navigation-system-plv.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/x-guide-surgical-navigation-system-plv
- 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.