Identity
- Trade Name
- U2 Acetabular Components, XPE Cup Liner FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- XPE Cup Liner, ID 32 mm, 10°× 74mm FDA UDI
- Model / Reference
- 1403-1274 FDA UDI
- Description
- XPE Cup Liner, ID 32 mm, 10°× 74mm FDA UDI
Identifiers
- Catalog Number
- 1403-1274 FDA UDI
- Primary DI / UDI-DI
- 04712771483970 FDA UDI
- 510(k) Number
- K111546 FDA UDI
- FDA Product Code
- LPH FDA UDIJDI FDA UDI
- GMDN Term
- Metal-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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 — 74 Millimeter FDA UDILumen/Inner Diameter — 32 Millimeter FDA UDIAngle — 10 degree FDA UDI
Category: Metal-on-polyethylene total hip prosthesis
U2 Acetabular Components, XPE Cup Liner by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-on-polyethylene total hip prosthesis.
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- Conformis Hip System — Conformis, Inc. · Class II
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- Initia Total Hip System — Kyocera Corporation · Class II
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Cleared under the same submission
K111546 also covers:
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System, Femoral Head — UNITED ORTHOPEDIC CORP.
- U1 Hip System, Femoral Head — UNITED ORTHOPEDIC CORP.
- U1 Hip System, Femoral Head — UNITED ORTHOPEDIC CORP.
- U1™ Hip — UNITED ORTHOPEDIC CORP.
- U2 Acetabular Components — UNITED ORTHOPEDIC CORP.
- U2 Acetabular Components — UNITED ORTHOPEDIC CORP.
- U2 Acetabular Components — UNITED ORTHOPEDIC CORP.
- U2 Acetabular Components — UNITED ORTHOPEDIC CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (1)
- FDA UDI cebe2251-778f-4154-a460-cfdc9739959e 37 fields · synced May 31, 2026