Identity
- Trade Name
- United U2 Hip Stem EUDAMEDU2 Hip Stem, HA/Ti Plasma Spray FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- U2 Hip Stem HA/Ti Plasma Spray, #2 Proximal, 11mm Dia. Distal EUDAMEDUNITED U2 Hip stem, HA/Ti plasma spray, #2, Ø11 FDA UDI
- Model / Reference
- 1104-1024 EUDAMEDFDA UDI
- Description
- UNITED U2 Hip stem, HA/Ti plasma spray, #2, Ø11 FDA UDI
Identifiers
- Catalog Number
- 1104-1024 FDA UDI
- Primary DI / UDI-DI
- 04712602340250 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04712602340250 EUDAMED
- 510(k) Number
- K003237 FDA UDI
- FDA Product Code
- LPH FDA UDIMEH FDA UDI
- EMDN Code
- P090804010201 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT EUDAMED
- GMDN Term
- Metal-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 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-04712602340250 | 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 d73acf4b-6b21-498a-ad7c-491b3690a26c 61 fields · synced Oct 6, 2026
- FDA UDI 78e30c69-e27b-4148-818a-c19052392e39 37 fields · synced May 30, 2026