Identity
- Trade Name
- TracOne Uni Knee System FDA UDI
- Generic Name
- Uncoated knee tibia prosthesis, metallic FDA UDI
- Device Name
- Tibial Baseplate, Cemented, Grit Blast, RL/LM, 0 FDA UDI
- Model / Reference
- 2602-0-0000 FDA UDI
- Description
- Tibial Baseplate, Cemented, Grit Blast, RL/LM, 0 FDA UDI
Identifiers
- Catalog Number
- 2602-0-0000 FDA UDI
- Primary DI / UDI-DI
- 00840286834070 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
Yes
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
TracOne Uni Knee System by Shalby Advanced Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated knee tibia prosthesis, metallic.
- Natural-Knee® — Zimmer, Inc. · Class II
- Biomet® Knee System — Biomet Orthopedics, Inc. · Class II
- Evolution — MicroPort Orthopedics Inc. · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- NexGen® — Zimmer, Inc. · Class II
- Optetrak — Exactech, Inc. · Class II
- ATTUNE — DEPUY (IRELAND) · Class III
- MOBIO™ Total Knee System — b-ONE Ortho Corp. · 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
- Shalby Advanced Technologies, Inc.
Sources (1)
- FDA UDI bda8b397-0055-4457-99e8-eff6e8be83d5 35 fields · synced May 31, 2026