X-Guide

Ref P008296

X-Guide (P008296) is a surgical planning/navigation-enhancement system (EU MDR Class IIa; FDA Class II; FDA product code PLV, Dental Stereotaxic Instrument) made by X-Nav Technologies, LLC, registered in EUDAMED on 28 Oct 2025 (Basic UDI-DI 081742102XGUIDEPLAN4K), cleared under FDA 510(k) K150222 on 8 Oct 2015 and listed in FDA GUDID since 30 Sep 2016 (UDI-DI 00817421020001), active as of 22 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150222

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number081742102XGUIDEPLAN4K Basic UDI-DI 00817421020001UDI-DI	Date28 Oct 2025Registered	StatusActive
United States	GUDID listing GUDID	Number00817421020001 UDI-DI	Date30 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK150222	Date8 Oct 2015Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 081742102XGUIDEPLAN4K — open Devices and search for it
AccessGUDID record UDI-DI 00817421020001
FDA 510(k) database 510(k) number K150222

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 081742102XGUIDEPLAN4K registered 28 Oct 2025 Active
FDA 510(k) K150222 decided 8 Oct 2015 Active
FDA GUDID UDI-DI 00817421020001 listed 30 Sep 2016 Listed

Recalls

1 recall · FDA

- Terminated Z-1391-2016 FDA Class II initiated 23 Feb 2016
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

Timeline

4 dated events

8 Oct 2015 Cleared FDA 510(k) K150222
23 Feb 2016 Recall initiated FDA recalls Z-1391-2016
30 Sep 2016 Listed FDA GUDID 00817421020001
28 Oct 2025 Registered EUDAMED 081742102XGUIDEPLAN4K

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name: Surgical planning/navigation-enhancement system
Device name: X-Guide Planning Software
Model / Ref / Catalog: P008296

Primary DI / UDI-DI: 00817421020001
Basic UDI-DI: 081742102XGUIDEPLAN4K
Direct marketing DI: 00817421020001
510(k) Number: K150222
FDA product code: PLV
EMDN code: Z12011492 Surgical navigation instruments - medical device software
GMDN term: Surgical planning/navigation-enhancement system

Device class: Class IIa EUDAMED
Class II GUDID
Regulation number: 872.4120
Special device type: Software
EU registration type: Standard device
EU market of registration: Netherlands
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN: US-MF-000003234
Authorised representative: Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from X-Nav Technologies, LLC

X-Guide P011265

Class II
X-Guide P011266

Class II
X-Guide P011268

Class II
X-Guide P011271

Class II

See all devices from X-Nav Technologies, LLC →

Properties

Prescription use

Other properties (24, all answered No)