Identity
- Trade Name
- MOBIO™ Total Knee System FDA UDI
- Generic Name
- Posterior-stabilized total knee prosthesis FDA UDI
- Device Name
- PS+ Tibial Insert, Size DE/3-7+, 11mm thickness, Vitamin E UHMWPE FDA UDI
- Model / Reference
- 8821343311 FDA UDI
- Description
- PS+ Tibial Insert, Size DE/3-7+, 11mm thickness, Vitamin E UHMWPE FDA UDI
Identifiers
- Catalog Number
- 8821343311 FDA UDI
- Primary DI / UDI-DI
- 00843575105745 FDA UDI
- FDA Product Code
- OIY FDA UDIJWH FDA UDI
- GMDN Term
- Posterior-stabilized total knee prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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: Posterior-stabilized total knee prosthesis
MOBIO™ Total Knee System by b-ONE Ortho Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Posterior-stabilized total knee prosthesis.
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- Evolution — MicroPort Orthopedics Inc. · Class II
- Evolution — MicroPort Orthopedics Inc. · Class II
- Consensus MBK System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · 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 |
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Manufacturer
- Manufacturer
- b-ONE Ortho Corp.
Sources (1)
- FDA UDI 846d9c7a-586e-4615-bd99-0bc0a57a53de 34 fields · synced May 31, 2026