ATTUNE AOX AFFIXIUM 151821041

GUDID 10603295523635

ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALIZED DOME 41mm

DEPUY (IRELAND)

Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis

• Primary Device ID: 10603295523635
• NIH Device Record Key: a2fb992a-eabf-4a56-aae6-26d2980e42f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATTUNE AOX AFFIXIUM
• Version Model Number: 1518-21-041
• Catalog Number: 151821041
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295523635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202194

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: 2020-12-14
• Device Publish Date: 2020-12-04

On-Brand Devices [ATTUNE AOX AFFIXIUM]

• 10603295523789: ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALIZED ANATOMIC 41mm
• 10603295523772: ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALIZED ANATOMIC 38mm
• 10603295523765: ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALIZED ANATOMIC 35mm
• 10603295523758: ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALIZED ANATOMIC 32mm
• 10603295523635: ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALIZED DOME 41mm
• 10603295523628: ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALIZED DOME 38mm
• 10603295523611: ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALIZED DOME 35mm
• 10603295523604: ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALIZED DOME 32mm