Identity
- Trade Name
- ROSA® EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- ROSA robot system Group 5 – Sterile Instruments Class IIa EUDAMED
- Model / Reference
- 20-8020-160-00 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 20-8020-160-00 FDA UDI
- Primary DI / UDI-DI
- 00887868552144 EUDAMEDFDA UDI
- Basic UDI-DI
- 889024-ZB001869-HA EUDAMED
- 510(k) Number
- K230243 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class IIa 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-purpose stereotactic surgery system
Rosa® by Zimmer CAS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-ZB001869-HA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 463b217e-fe56-4915-81da-5b18b911090b 61 fields · synced Jul 25, 2026
- FDA UDI 7055158c-26e2-4d86-a2ab-15d29770a023 36 fields · synced May 30, 2026