Identity
- Trade Name
- United U2 Hip Stem EUDAMEDU2 Hip Stem, Revision Hip Stem Collarless, Curved FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- U2 Hip Stem Revision Hip Stem, Collarless, Curved, 13mm Dia., 230mm Stem Length, Left EUDAMEDRevision hip stem, Ti plasma spray, Collarless, Curved, Left, Ø13x230mm FDA UDI
- Model / Reference
- 1104-1713 EUDAMEDFDA UDI
- Description
- Revision hip stem, Ti plasma spray, Collarless, Curved, Left, Ø13x230mm FDA UDI
Identifiers
- Catalog Number
- 1104-1713 FDA UDI
- Primary DI / UDI-DI
- 04712602340663 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04712602340663 EUDAMED
- 510(k) Number
- K062978 FDA UDI
- FDA Product Code
- LWJ FDA UDI
- EMDN Code
- P090804030201 REVISION UNCEMENTED FEMORAL STEMS, WITH FIXED NECK EUDAMED
- GMDN Term
- Metal-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3360 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
United U2 Hip Stem by United Orthopedic Corporation — Class III — 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-04712602340663 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | 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 6fa98b3b-81ad-4bc3-92fa-bfaa73bb9e0b 61 fields · synced Oct 6, 2026
- FDA UDI 11b531b9-4e5d-4b3e-9ed1-482e7aad165f 37 fields · synced May 30, 2026