Identity
- Trade Name
- BIRMINGHAM HIP RESURFACING (BHR) FDA UDI
- Generic Name
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
- Device Name
- FEMORAL HEAD 48MM FDA UDI
- Model / Reference
- 74123148 FDA UDI
- Description
- FEMORAL HEAD 48MM FDA UDI
Identifiers
- Catalog Number
- 74123148 FDA UDI
- Primary DI / UDI-DI
- 03596010552426 FDA UDI
- PMA Number
- P040033 FDA UDI
- FDA Product Code
- NXT FDA UDI
- GMDN Term
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
Classification
- Device Class
- Class III 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
Category: Bipolar femoral head outer component, hemiarthroplasty
Birmingham Hip Resurfacing (bhr) by Smith & Nephew, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bipolar femoral head outer component, hemiarthroplasty.
- Pivot Bipolar — ORTHO DEVELOPMENT CORP. · Class II
- BIO-MOORE ENDO II HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Endohead — Medacta International · Class II
- UHR — Howmedica Osteonics Corp. · Class II
- SLR BIPOLAR — MicroPort Orthopedics Inc. · Class II
- MultiPolar® — Zimmer, Inc. · Class II
- United Hip System, U2 Bipolar Implant — UNITED ORTHOPEDIC CORP. · Class II
Cleared under the same submission
P040033 also covers:
- BIRMINGHAM HIP — Smith & Nephew, Inc.
- BIRMINGHAM HIP — Smith & Nephew, Inc.
- BIRMINGHAM HIP — Smith & Nephew, Inc.
- BIRMINGHAM HIP — Smith & Nephew, Inc.
- BIRMINGHAM HIP — Smith & Nephew, Inc.
- BIRMINGHAM HIP — Smith & Nephew, Inc.
- BIRMINGHAM HIP — Smith & Nephew, Inc.
- BIRMINGHAM HIP — Smith & Nephew, Inc.
- BIRMINGHAM HIP — Smith & Nephew, Inc.
- BIRMINGHAM HIP — Smith & Nephew, Inc.
- BIRMINGHAM HIP — Smith & Nephew, Inc.
- BIRMINGHAM HIP — Smith & Nephew, Inc.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI d4c7274e-f8ed-4ae2-840e-a91192827e30 36 fields · synced Jun 8, 2026