Identity
- Trade Name
- U2 Acetabular Components EUDAMEDU2 Acetabular Components, HA/Ti Plasma Spray FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- U2 Acetabular Components HA/Ti Plasma Spray, 62mm O.D. EUDAMEDU2 Acetabular cup, HA/Ti plasma spray, Ø62mm FDA UDI
- Model / Reference
- 1303-5262 EUDAMEDFDA UDI
- Description
- U2 Acetabular cup, HA/Ti plasma spray, Ø62mm FDA UDI
Identifiers
- Catalog Number
- 1303-5262 FDA UDI
- Primary DI / UDI-DI
- 04712602342308 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04712602342308 EUDAMED
- 510(k) Number
- K050262 FDA UDI
- FDA Product Code
- LWJ FDA UDIMEH FDA UDI
- EMDN Code
- P090803010201 PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPS 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 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
Dimensions & Sizes
- Size
- Outer Diameter — 62 Millimeter FDA UDI
U2 Acetabular Components 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-04712602342308 | 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 88a52c7c-2be3-4b39-9069-ea8ccaebc7f4 61 fields · synced Jul 16, 2026
- FDA UDI 94a84826-73b4-424d-a4a8-89a6d95d4363 37 fields · synced May 25, 2026