Consensus Knee System with TiNbN 2268-0-0004

GUDID 00840286851640

CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 4

Shalby Advanced Technologies, Inc.

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 00840286851640
• NIH Device Record Key: 4b2a5e8b-3774-4054-9c58-531a2a3432b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Consensus Knee System with TiNbN
• Version Model Number: 2268-0-0004
• Catalog Number: 2268-0-0004
• Company DUNS: 085976260
• Company Name: Shalby Advanced Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us
• Phone: +1(916)355-7100
• Email: khansen@shalby.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840286851640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241180

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-24
• Device Publish Date: 2025-02-14

On-Brand Devices [Consensus Knee System with TiNbN]

• 00840286851664: CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 6
• 00840286851657: CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 5
• 00840286851640: CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 4
• 00840286851633: CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 3
• 00840286851626: CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 2
• 00840286851619: CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 1
• 00840286851602: CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 6
• 00840286851596: CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 5
• 00840286851589: CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 4
• 00840286851572: CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 3
• 00840286851565: CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 2
• 00840286851558: CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 1