867412

GUDID 10603295217817

UNIVERSAL STEM FLUTED 75mm x 12mm

DEPUY ORTHOPAEDICS, INC.

Knee femur stem prosthesis

• Primary Device ID: 10603295217817
• NIH Device Record Key: ff0449b5-0f3f-4283-96aa-d3ff5bc5fa94
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 86-7412
• Catalog Number: 867412
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, 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(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	10603295217817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063633

FDA Product Code

• NJL: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-20
• Device Publish Date: 2015-03-24

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

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• 10603295552833 - INHANCETM: 2025-05-23 INHANCETM MAKE TO ORDER INTRAMEDULLARY HUMERAL RESECTION GUIDE LEFT
• 10603295552666 - SUMMIT: 2025-05-08 SUMMIT MAKE TO ORDER LATERAL OFFSET ANT APPROACH BROACH HANDLE RIGHT
• 10603295552765 - SUMMIT: 2025-05-08 SUMMIT MAKE TO ORDER LATERAL OFFSET ANT APPROACH BROACH HANDLE LEFT