Identity
- Trade Name
- United Hip System EUDAMEDU-Motion II PS+ Cup, no-hole FDA UDI
- Generic Name
- Ceramic-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- United Hip System U-Motion II PS+ Cup, No-Hole, 70mm O.D. EUDAMEDU-Motion II PS+ Cup, no-hole, Ø70mm FDA UDI
- Model / Reference
- 1306-3370 EUDAMEDFDA UDI
- Description
- U-Motion II PS+ Cup, no-hole, Ø70mm FDA UDI
Identifiers
- Catalog Number
- 1306-3370 FDA UDI
- Primary DI / UDI-DI
- 04711605568418 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04711605568418 EUDAMED
- 510(k) Number
- K132455 FDA UDI
- FDA Product Code
- LZO FDA UDIMEH FDA UDIKWY FDA UDILWJ FDA UDI
- EMDN Code
- P090803010201 PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPS EUDAMED
- GMDN Term
- Ceramic-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3390 FDA UDI888.3360 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 Hip System 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-04711605568418 | 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 1aff64bb-32ca-40c7-93db-799ba6a8811d 61 fields · synced Oct 6, 2026
- FDA UDI 18413081-6c79-40ff-90fc-5e72b925099d 37 fields · synced May 30, 2026