Duraniom 2267-0-0006

GUDID 00840286857574

Femoral Component, RLP, CR, TiNbN Coating, Left, Size 6

Shalby Advanced Technologies, Inc.

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 00840286857574
• NIH Device Record Key: 5f5ff8d1-c17f-451f-bf51-92b4de348812
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duraniom
• Version Model Number: 2267-0-0006
• Catalog Number: 2267-0-0006
• 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: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840286857574 [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: 2025-04-02
• Device Publish Date: 2025-03-25

On-Brand Devices [Duraniom]

• 00840286857871: Tibial Baseplate, Pegless, TiNbN Coating, Right, Size 2
• 00840286857864: Tibial Baseplate, Pegless, TiNbN Coating, Right, Size 1
• 00840286857857: Tibial Baseplate, Pegless, TiNbN Coating, Right, Size 0
• 00840286857840: Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 6
• 00840286857833: Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 5
• 00840286857826: Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 4
• 00840286857819: Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 3
• 00840286857802: Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 2
• 00840286857796: Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 1
• 00840286857789: Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 0
• 00840286857772: Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 6
• 00840286857765: Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 5
• 00840286857758: Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 4
• 00840286857741: Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 3
• 00840286857734: Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 2
• 00840286857727: Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 1
• 00840286857710: Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 0
• 00840286857703: Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 6
• 00840286857697: Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 5
• 00840286857680: Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 4
• 00840286857673: Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 3
• 00840286857666: Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 2
• 00840286857659: Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 1
• 00840286857642: Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 0
• 00840286857635: Femoral Component, RLP, CR, TiNbN Coating, Right, Size 6
• 00840286857628: Femoral Component, RLP, CR, TiNbN Coating, Right, Size 5
• 00840286857611: Femoral Component, RLP, CR, TiNbN Coating, Right, Size 4
• 00840286857604: Femoral Component, RLP, CR, TiNbN Coating, Right, Size 3
• 00840286857598: Femoral Component, RLP, CR, TiNbN Coating, Right, Size 2
• 00840286857581: Femoral Component, RLP, CR, TiNbN Coating, Right, Size 1
• 00840286857574: Femoral Component, RLP, CR, TiNbN Coating, Left, Size 6
• 00840286857567: Femoral Component, RLP, CR, TiNbN Coating, Left, Size 5
• 00840286857550: Femoral Component, RLP, CR, TiNbN Coating, Left, Size 4
• 00840286857543: Femoral Component, RLP, CR, TiNbN Coating, Left, Size 3
• 00840286857536: Femoral Component, RLP, CR, TiNbN Coating, Left, Size 2
• 00840286857529: Femoral Component, RLP, CR, TiNbN Coating, Left, Size 1
• 00840286858052: Tibial Baseplate, Holed, TiNbN Coating, Right, Size 6
• 00840286858045: Tibial Baseplate, Holed, TiNbN Coating, Right, Size 5
• 00840286858038: Tibial Baseplate, Holed, TiNbN Coating, Right, Size 4
• 00840286858021: Tibial Baseplate, Holed, TiNbN Coating, Right, Size 3
• 00840286858014: Tibial Baseplate, Holed, TiNbN Coating, Right, Size 2
• 00840286858007: Tibial Baseplate, Holed, TiNbN Coating, Right, Size 1
• 00840286857994: Tibial Baseplate, Holed, TiNbN Coating, Right, Size 0
• 00840286857987: Tibial Baseplate, Holed, TiNbN Coating, Left, Size 6
• 00840286857970: Tibial Baseplate, Holed, TiNbN Coating, Left, Size 5
• 00840286857963: Tibial Baseplate, Holed, TiNbN Coating, Left, Size 4
• 00840286857956: Tibial Baseplate, Holed, TiNbN Coating, Left, Size 3
• 00840286857949: Tibial Baseplate, Holed, TiNbN Coating, Left, Size 2
• 00840286857932: Tibial Baseplate, Holed, TiNbN Coating, Left, Size 1
• 00840286857925: Tibial Baseplate, Holed, TiNbN Coating, Left, Size 0