867421

GUDID 10603295217879

UNIVERSAL STEM FLUTED 75mm x 24mm

DEPUY ORTHOPAEDICS, INC.

Knee femur stem prosthesis

• Primary Device ID: 10603295217879
• NIH Device Record Key: 0555392d-a3e7-4561-ac48-d6864b750d91
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 86-7421
• Catalog Number: 867421
• 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	10603295217879 [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.

• 10603295553663 - ATTUNE: 2025-12-29 ATTUNE MAKE TO ORDER PS 3 IN 1 BLOCK SZ 5
• 10603295553670 - ATTUNE: 2025-12-29 ATTUNE MAKE TO ORDER PS 3 IN 1 BLOCK SZ 6
• 10603295553687 - ATTUNE: 2025-12-29 ATTUNE MAKE TO ORDER PS 3 IN 1 BLOCK SZ 7
• 10603295553694 - ATTUNE: 2025-12-29 ATTUNE MAKE TO ORDER PS 3 IN 1 BLOCK SZ 8
• 10603295553700 - ATTUNE: 2025-12-29 ATTUNE MAKE TO ORDER PS 3 IN 1 BLOCK SZ 9
• 10603295554929 - ATTUNE: 2025-12-29 ATTUNE MAKE TO ORDER PS 3 IN 1 BLOCK SZ 10
• 10603295554950 - N/A: 2025-12-15 MAKE TO ORDER UNITY TIBIAL KEEL RASP
• 10603295553519 - INHANCE: 2025-10-07 INHANCE MAKE TO ORDER PIN DRILL GUIDE - SMALL