Identity
- Trade Name
- U2 Acetabular Components EUDAMEDU2 Acetabular Components, Cup Liner FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- U2 Acetabular Components Cup Liner, 10 Degrees Anteverted, 26mm I.D., 58mm O.D. EUDAMEDU2 Acetabular cup liner,ID 26mm 10°hooded,58mm FDA UDI
- Model / Reference
- 1403-5258 EUDAMEDFDA UDI
- Description
- U2 Acetabular cup liner,ID 26mm 10°hooded,58mm FDA UDI
Identifiers
- Catalog Number
- 1403-5258 FDA UDI
- Primary DI / UDI-DI
- 04712602343237 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04712602343237 EUDAMED
- 510(k) Number
- K050262 FDA UDI
- FDA Product Code
- LWJ FDA UDIMEH 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
- 888.3360 FDA UDI888.3353 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 58 Millimeter FDA UDILumen/Inner Diameter — 26 Millimeter FDA UDI
Category: Non-constrained polyethylene acetabular liner
U2 Acetabular Components by United Orthopedic Corporation — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-constrained polyethylene acetabular liner.
- C-Fit & DC-Fit Acetabular Cup System — CORIN LTD · Class II
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG · Class II
- PRIME — MicroPort Orthopedics Inc. · Class II
- G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04712602343237 | 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 544b0442-5849-42eb-abab-2b0c023c6ce2 61 fields · synced Jun 9, 2026
- FDA UDI f305a6c5-f52f-4a10-b98f-956ecece4200 37 fields · synced May 30, 2026