Identity
- Trade Name
- U2 Acetabular Components EUDAMEDU2 Acetabular Components, Cancellous Screw FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- U2 Acetabular Components Cancellous Screw, 6.5mm Dia., 35mm Length EUDAMEDTitanium cancellous bone screw, 35 mm FDA UDI
- Model / Reference
- 5201-6735 EUDAMEDFDA UDI
- Description
- Titanium cancellous bone screw, 35 mm FDA UDI
Identifiers
- Catalog Number
- 5201-6735 FDA UDI
- Primary DI / UDI-DI
- 04712602344821 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04712602344821 EUDAMED
- 510(k) Number
- K050262 FDA UDI
- FDA Product Code
- LWJ FDA UDIMEH FDA UDI
- EMDN Code
- P09088007 HIP PROSTHESES FIXING SCREWS EUDAMED
- GMDN Term
- Metal-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class IIb 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
- Length — 35 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
U2 Acetabular Components by United Orthopedic Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
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- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
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-04712602344821 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 212cd7f9-4e7d-4afa-9fb8-6921c40ee975 61 fields · synced Jun 9, 2026
- FDA UDI c9c6c8b3-a218-4a0b-a861-96a109b4be36 37 fields · synced May 30, 2026