Identity
- Trade Name
- b-ONE™ Primary Acetabular System FDA UDI
- Generic Name
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
- Device Name
- ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE I X 32MM I.D. FDA UDI
- Model / Reference
- 881906432I FDA UDI
- Description
- ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE I X 32MM I.D. FDA UDI
Identifiers
- Catalog Number
- 881906432I FDA UDI
- Primary DI / UDI-DI
- 00843575104069 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Acetabulum prosthesis trial, prefabricated, reusable
b-ONE™ Primary Acetabular System by b-ONE Ortho Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabulum prosthesis trial, prefabricated, reusable.
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- Novation — Exactech, Inc. · Class I
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- INSTRUMENT — Howmedica Osteonics Corp. · Class II
- MultiPolar® — Zimmer, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- b-ONE Ortho Corp.
Sources (1)
- FDA UDI df55746c-9668-4786-996a-1800be51b82a 34 fields · synced May 31, 2026