Manufacturer

Kico Knee Innovation Pty

AustraliaLegal entities : Kico Knee Innovation Company Pty Ltd

Markets : Germany · Italy · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 6 · class I, II · latest in 2025 · see on the FDA website

EU representative : MedEnvoy Global BV (Netherlands)

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

Category	EMDN code	Registered models	Class	Contact
Surgical navigation instruments - hardware accessories	Z12011480	[ARVIS - Instruments] Flex Jack [ARVIS - Instruments] Mounts and Adapters3 refs [ARVIS - Instruments] Registration Stylus, Hip and Knee [ARVIS - Instruments] Tracker A, B, C3 refs [ARVIS - Instruments] Tracker D 10 others [ARVIS] Belt Pack2 refs [ARVIS] Eyepiece Assembly2 refs [ARVIS] Flyte Mounting Kit2 refs [ARVIS] Headband2 refs [ARVIS] T7 Adapter Kit2 refs Arvis5 refs ARVIS Instrument - SS8 Mount Kit ARVIS Shoulder Instrument Set 2.0 Mechanical Mount IN-23000 Tracker A, Mechanical2 refs	I, IIa MDR	EUDAMED record Report an error
Surgical navigation instruments - software accessories	Z12011482	ARVIS Hip and Knee Gap Balance Application Arvis IN-12705 Arvis IN-12706 ARVIS Shoulder Software Application 2.0	IIa MDR	EUDAMED record Report an error
Surgical navigation system	Z12011401	ARVIS	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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