Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instrumentsSurgical navigation instruments

Surgical navigation instruments - software accessories

EMDN code Z12011482

10 manufacturers, 33 models including 32 on the market, 7 countries

On the market in Models on the market only Manufacturer country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Blue Ortho FDA	France	ExactechGPS Total Ankle Case Manager Application ExactechGPS Total Ankle Navigation Application GPS Ankle - Case Manager2 refs GPS ApplicationSystem GPS Knee - TKA Pro 5 others GPS Shoulder - Navigation2 refs Shoulder Planning App TKA Plus TKA Pro TSA Navigation	I, IIa MDR	Website info@blue-ortho.com EUDAMED record Report an error
Brainlab FDA	Germany	Alignment Software Spine, 2.02 refs Automatic Registration iMRI, 1.13 refs Automatic Registration, 2.593/42 Cranial IGS System Ultrasound Navigation, 1.193/42 Microscope Navigation, 1.693/42 5 others Microscope Navigation, 1.7 Mixed Reality Spine Navigation, 1.02 refs Registration Fluoro 3D, 1.5 Ultrasound Navigation, 1.2 Cranial IGS System Automatic Registration iMRI, 1.093/42 (no longer marketed)	IIb MDR, 93/42	regulatory.affairs@brainlab.com EUDAMED record Report an error
Kico Knee Innovation Pty FDA EU representative : MedEnvoy Global BV (Netherlands)	Australia	ARVIS Hip and Knee Gap Balance Application Arvis IN-12705 Arvis IN-12706 ARVIS Shoulder Software Application 2.0	IIa MDR	Website EUDAMED record Report an error
Aesculap FDA	Germany	ORTHOPILOT software THA universal V2 ORTHOPILOT software TKA version 6 ORTHOPILOT software TKR version 3	IIa MDR	Website eudamed@bbraun.com EUDAMED record Report an error
CART-Tech	Netherlands	CARTBox-Suite Light	IIb MDR	Website EUDAMED record Report an error
Cydar FDA EU representative : Emergo Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	Cydar Maps EV3 refs	IIb MDR	Website regulatory@cydar.co.uk EUDAMED record Report an error
Ergosurg	Germany	ENT Navigation Software93/42	I 93/42	Website info@ergosurg.com EUDAMED record Report an error
iSYS Medizintechnik FDA	Austria	Micromate Navi+	I MDR	Website info@interventional-systems.com EUDAMED record Report an error
Stereotaxis FDA EU representative : MDSS GmbH (Germany)	United States	Navigant 5.2	IIb MDR	Info@stereotaxis.com EUDAMED record Report an error
Therenva FDA	France	EndoNaut Server Main Display SW v1.3.x	I MDR	Website contact@therenva.com EUDAMED record Report an error

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