Identity
- Trade Name
- ARVIS ® FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Mechanical Mount EUDAMEDFDA UDI
- Model / Reference
- IN-23000 EUDAMEDFDA UDI
- Description
- Mechanical Mount FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810180350259 EUDAMEDFDA UDI
- Basic UDI-DI
- 08889120000Z120114800B1G2 EUDAMED
- Direct Marketing DI
- 00810180350259 EUDAMED
- 510(k) Number
- K240062 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Arvis ® by Kico Knee Innovation Company Pty Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kico Knee Innovation Company Pty Limited
Sources (2)
- FDA UDI 63906772-1d71-4de0-9131-7ae1c33fd03e 34 fields · synced Jun 11, 2026
- EUDAMED 3e9d21ce-9cc1-48d6-8a50-9afa69db6c08 61 fields · synced Jun 11, 2026