Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011764595

FEI Number

3011764595

Entity Name

X-NAV TECHNOLOGIES, LLC.

City/State/Country

Lansdale, PA, US

Establishment Address

1555 Bustard Road, Suite 75 & 110, Lansdale, PA 19446, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

X-NAV Technologies, LLC. (Owner Number: 10049672)

Owner / Operator Contact Address

1555 Bustard Road, Suite 75, Lansdale, PA 19446, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150222

PMA Number

N/A

All Registered Proprietary Names

X-Guide FastMap FastMap FastMap Navigated Photogrammetry X-Guide Surgical Navigation System EDX Bone Screw EDX Tracker Arm IconiX AI X-Guide X-Guide IconiX AI IconiX X-Guide NXT X-Guide System X-Guide Surgical Navigation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2024-03-13
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2020-05-21
PLV	Dental Stereotaxic Instrument	Dental	Class 2	872.4120	2020-05-21
QRY	Dental Navigation System	Dental	Class 2	872.4120	2024-03-13
PLV	Dental Stereotaxic Instrument	Dental	Class 2	872.4120	2024-03-13
PLV	Dental Stereotaxic Instrument	Dental	Class 2	872.4120	2015-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

X-NAV Technologies, LLC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011764595. Last updated year: 2026. Please use registration number 3011764595 when referencing this establishment in official correspondence.