Identity
- Trade Name
- WHITE BOX FDA UDI
- Generic Name
- Metallic acetabulum prosthesis FDA UDI
- Device Name
- PRIMARY HIP SHELL 46MM POROUS COAT GROUP B FDA UDI
- Model / Reference
- HWBOGB46 FDA UDI
- Description
- PRIMARY HIP SHELL 46MM POROUS COAT GROUP B FDA UDI
Identifiers
- Catalog Number
- HWBOGB46 FDA UDI
- Primary DI / UDI-DI
- M684HWBOGB461 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Metallic acetabulum prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 46 Millimeter FDA UDI
Category: Metallic acetabulum prosthesis
White Box by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic acetabulum prosthesis.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc. · Class II
- Platform Acetabular Cup with Ti-Coat — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- b-ONE™ Primary Acetabular System — b-ONE Ortho Corp. · Class II
- Contour — Smith & Nephew, Inc. · Class II
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- DELTA TT Pro — Limacorporate · Class II
- Mpact 3D Metal — Medacta International · Class II
- BENCOX Hip System — Corentec Co., Ltd · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI 86881ef5-8396-4422-b5ca-808f74cf3206 36 fields · synced Jun 9, 2026