Identity
- Trade Name
- Consensus Knee System FDA UDI
- Generic Name
- Uncoated knee tibia prosthesis, polyethylene FDA UDI
- Device Name
- Tibial Component, All Poly, Cemented, 2, 18mm FDA UDI
- Model / Reference
- 2660-0-2018 FDA UDI
- Description
- Tibial Component, All Poly, Cemented, 2, 18mm FDA UDI
Identifiers
- Catalog Number
- 2660-0-2018 FDA UDI
- Primary DI / UDI-DI
- 00840286834254 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Uncoated knee tibia prosthesis, polyethylene 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, polyethylene
A comprehensive medical device directory listing the Consensus Knee System, a uncoated knee tibia prosthesis made entirely of polyethylene. This implantable device replaces the tibial condyles during primary bicondylar replacement or to replace a dysfunctional knee prosthesis.
Similar devices
Also classified as Uncoated knee tibia prosthesis, polyethylene.
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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 2e551431-2060-40be-b974-2ec224507c5c 35 fields · synced Jul 30, 2026