← Back to catalogue
Rosa Ppk Med Cut Guide A-R
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 20-8020-031-00
by Zimmer CAS
Identity
- Trade Name
- ROSA PPK MED CUT GUIDE A-R EUDAMEDROSA® FDA UDI
- Generic Name
- Osteotomy guide, reusable FDA UDI
- Device Name
- PPK ROSA robot system Group 1 – Instruments Class Iia EUDAMED
- Model / Reference
- 20-8020-031-00 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024593992 EUDAMEDFDA UDI
- Basic UDI-DI
- 889024-ZB004120-FB EUDAMED
- 510(k) Number
- K210121 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Osteotomy guide, reusable 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Rosa Ppk Med Cut Guide A-R by Zimmer CAS — Class IIa — 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-ZB004120-FB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zimmer CAS
- EUDAMED SRN
- CA-MF-000000791
- Authorised Representative
- Biomet Global Supply Chain Center B.V. NL-AR-000000422
Sources (2)
- EUDAMED 994ee9a9-f602-4579-839d-29d821cad4a9 61 fields · synced Jul 9, 2026
- FDA UDI 6eeae565-c2d0-43f9-be18-4a767e09f122 34 fields · synced May 30, 2026