Identity
- Trade Name
- CKS Plus FDA UDI
- Generic Name
- Uncoated knee tibia prosthesis, metallic FDA UDI
- Device Name
- 6mm Tibial BP, Stemmed, Hole, No Peg, Full Wrap, R, 1, 3° Slope FDA UDI
- Model / Reference
- 2596-0-6321 FDA UDI
- Description
- 6mm Tibial BP, Stemmed, Hole, No Peg, Full Wrap, R, 1, 3° Slope FDA UDI
Identifiers
- Catalog Number
- 2596-0-6321 FDA UDI
- Primary DI / UDI-DI
- 00840286830218 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
A comprehensive knee replacement solution for individuals with severe knee joint damage or dysfunction. Designed to provide reliable and durable results, the CKS Plus is a high-quality, uncoated prosthesis that addresses the need for orthopedic care.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shalby Advanced Technologies, Inc.
Sources (1)
- FDA UDI 06b93a3f-d417-463b-b92e-29cd45e6c1e9 35 fields · synced Jun 22, 2026