Consensus Knee System/Revision Knee System 2944-1-3418

GUDID 00840286843737

CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 18mm

Shalby Advanced Technologies, Inc.

Knee tibia prosthesis trial, reusable

• Primary Device ID: 00840286843737
• NIH Device Record Key: c496998a-1d4b-4eee-9ed6-f502f467e706
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Consensus Knee System/Revision Knee System
• Version Model Number: 2944-1-3418
• Catalog Number: 2944-1-3418
• Company DUNS: 085976260
• Company Name: Shalby Advanced Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840286843737 [Primary]

FDA Product Code

• HWT: Template

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

[00840286843737]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-22
• Device Publish Date: 2025-05-14

On-Brand Devices [Consensus Knee System/Revision Knee System]

• 00840286855099: Femoral/Tibial Impactor Head Small/Large
• 00840286855082: Femoral/Tibial Impactor Head Small/Large
• 00840286843843: CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 10mm
• 00840286843836: CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 12mm
• 00840286843829: CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 14mm
• 00840286843812: CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 16mm
• 00840286843805: CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 18mm
• 00840286843799: CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 20mm
• 00840286843782: CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 22mm
• 00840286843775: CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 10mm
• 00840286843768: CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 12mm
• 00840286843751: CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 14mm
• 00840286843744: CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 16mm
• 00840286843737: CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 18mm
• 00840286843720: CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 20mm