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Rosa® Knee Optical Unit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 20-8020-120-01
by Zimmer CAS
Identity
- Trade Name
- ROSA® KNEE OPTICAL UNIT EUDAMEDFDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- ROSA Recon Platform Group 2 EUDAMED
- Model / Reference
- 20-8020-120-01 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 20-8020-120-01 FDA UDI
- Primary DI / UDI-DI
- 00889024511323 EUDAMEDFDA UDI
- Basic UDI-DI
- 889024-ZB001155-F8 EUDAMED
- 510(k) Number
- K182964 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130401 STEREOTACTIC ORTHOPAEDIC SURGERY SYSTEMS EUDAMED
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Rosa® Knee Optical Unit by Zimmer CAS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 889024-ZB001155-F8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zimmer CAS
- EUDAMED SRN
- CA-MF-000000791
- Authorised Representative
- Biomet Global Supply Chain Center B.V. NL-AR-000000422
Sources (2)
- EUDAMED c2db0294-3a76-4553-958f-343b1a8ff53d 61 fields · synced Jul 20, 2026
- FDA UDI 337520c4-19a7-4d1b-aa7c-2140a80a564a 35 fields · synced May 29, 2026