Data / Medical devices / United States / X-Nav Technologies, LLC.

X-Nav Technologies, LLC.: FDA-registered device maker in Lansdale, PA, United States, 6 510(k) clearances

Name: X-Nav Technologies, LLC. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

X-Nav Technologies, LLC. is registered with the FDA (registration 3011764595) in Lansdale, PA, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 28, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3011764595
Address: 1555 Bustard Road, Suite 75 & 110, Lansdale, PA, United States, 19446
Owner or operator: X-NAV Technologies, LLC. (10049672)
Roles: Complaint file establishment, Manufacturer
First device listed: October 22, 2015
Registered through: 2026
Brand names listed: EDX Bone Screw, EDX Tracker Arm, FastMap, FastMap Navigated Photogrammetry, IconiX, IconiX AI, Straight Cuts, ToolTrace and more

Devices it lists

Device	Product code	Class	Role	Source
Dental Navigation System	QRY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Dental Stereotaxic Instrument	PLV	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Screw, Fixation, Intraosseous	DZL	2	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 28, 2026	K253954	X-Guide Surgical Navigation System	QRY	Substantially Equivalent	X-Nav Technologies, LLC	accessdata.fda.gov
February 21, 2024	K232148	X-Guide Surgical Navigation System	QRY	Substantially Equivalent	X-Nav Technologies, LLC	accessdata.fda.gov
February 1, 2022	K211701	X-Guide® Surgical Navigation System	QRY	Substantially Equivalent	X-Nav Technologies, LLC	accessdata.fda.gov
May 21, 2020	K200662	X-Guide® Surgical Navigation System	PLV	Substantially Equivalent	X-Nav Technologies, LLC	accessdata.fda.gov
February 3, 2020	K192579	X-Guide Surgical Navigation System	PLV	Substantially Equivalent	X-Nav Technologies, LLC	accessdata.fda.gov
October 8, 2015	K150222	X-Guide Surgical Navigation System	PLV	Substantially Equivalent	X-Nav Technologies, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 4, 2024	94175	Class II	Ongoing	X-Guide Handpiece Adaptor Sleeve 1, Model P010701	The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.	accessdata.fda.gov
September 28, 2022	91067	Class II	Ongoing	X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673	Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip.	accessdata.fda.gov
February 23, 2016	73544	Class II	Terminated	X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operat	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	accessdata.fda.gov

Compare with other makers

Updated August 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.