Identity
- Trade Name
- USTAR II Knee System EUDAMEDFDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- USTAR II Cemented stem trial body, curved, Ø15×200mm EUDAMEDFDA UDI
- Model / Reference
- 9315-9415 EUDAMEDFDA UDI
- Description
- USTAR II Cemented stem trial body, curved, Ø15×200mm FDA UDI
Identifiers
- Catalog Number
- 9315-9415 FDA UDI
- Primary DI / UDI-DI
- 04719886903584 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04719886903584 EUDAMED
- 510(k) Number
- K190100 FDA UDI
- FDA Product Code
- KRO FDA UDILPH FDA UDILWJ FDA UDIKWL FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Femoral stem prosthesis trial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3510 FDA UDI888.3358 FDA UDI888.3360 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
USTAR II Knee System by United Orthopedic Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719886903584 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corporation
- EUDAMED SRN
- TW-MF-000009523
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 599ca1a7-fa3d-43c1-ad4c-122fda46cebe 61 fields · synced Oct 6, 2026
- FDA UDI 8803cf0f-1f95-45ff-ace6-5dc1dfe527bd 36 fields · synced May 30, 2026