Identity
- Trade Name
- U2 Acetabular Components EUDAMEDU2 Acetabular Components, XPE Cup Liner FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- U2 Acetabular Components XPE Cup Liner, 0 Degree, 32mm I.D., 64mm O.D. EUDAMEDXPE cup liner, ID32mm, 0°×64mm FDA UDI
- Model / Reference
- 1403-1364 EUDAMEDFDA UDI
- Description
- XPE cup liner, ID32mm, 0°×64mm FDA UDI
Identifiers
- Catalog Number
- 1403-1364 FDA UDI
- Primary DI / UDI-DI
- 04712771483390 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04712771483390 EUDAMED
- 510(k) Number
- K111546 FDA UDI
- FDA Product Code
- LPH FDA UDIJDI FDA UDI
- EMDN Code
- P090803040101 STANDARD POLYETHYLENE HIP PROSTHESES INSERTS 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 UDI888.3350 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 — 64 Millimeter FDA UDILumen/Inner Diameter — 32 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-04712771483390 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- United Orthopedic Corporation
- EUDAMED SRN
- TW-MF-000009523
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 6f275881-9d99-4b65-918d-b48b47c2ae95 61 fields · synced Jul 28, 2026
- FDA UDI dfb2bfa2-3ce9-4f3d-9387-cf69260486dd 37 fields · synced May 30, 2026