Identity
- Trade Name
- MOBIO™ Total Knee System FDA UDI
- Generic Name
- Uncoated knee tibia prosthesis, metallic FDA UDI
- Device Name
- Stemmed Tibial Baseplate, Size D FDA UDI
- Model / Reference
- 8821210400 FDA UDI
- Description
- Stemmed Tibial Baseplate, Size D FDA UDI
Identifiers
- Catalog Number
- 8821210400 FDA UDI
- Primary DI / UDI-DI
- 00843575119759 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Uncoated knee tibia prosthesis, metallic 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: Uncoated knee tibia prosthesis, metallic
MOBIO™ Total Knee System by b-ONE Ortho Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated knee tibia prosthesis, metallic.
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- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Biomet® Knee System — Biomet Orthopedics, Inc. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- CKS Plus — SHALBY ADVANCED 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 85beb0d7-8f9a-4194-b426-33eb7075ff5d 34 fields · synced May 30, 2026