Manufacturer

X-Nav Technologies

United StatesLegal entities : X-Nav Technologies, LLC

Markets : Netherlands · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 6 · class II · latest in 2026 · see on the FDA website

EU representative : Emergo Europe B.V. (Netherlands)

3 categories, 20 models including 20 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Surgical navigation instruments - consumables	Z12011485	EDX Bone Screw and Cap3 refs P00883593/42 P00883693/42 P00883793/42 P00884093/42 11 others P00884193/42 P00884293/42 P01092093/42 P01092193/42 P01092293/42 P01092393/42 P01092493/42 P01092593/42 X-Clip P009083 X-Guide BONE SCREW - 2.0 x 10mm - 3 ct.93/42 X-Guide P00884393/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Surgical navigation system	Z12011401	X-Guide P00783993/42 X-Guide P01100093/42 X-Guide System P0110002 refs	IIa MDR, 93/42	EUDAMED record Report an error
Surgical navigation instruments - medical device software	Z12011492	X-Guide P008296	IIa MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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