867446

GUDID 10603295218005

UNIVERSAL STEM FLUTED 150mm x 18mm

DEPUY ORTHOPAEDICS, INC.

Knee femur stem prosthesis

• Primary Device ID: 10603295218005
• NIH Device Record Key: e59b8eea-26ce-4b18-a5f4-3337d4f13a09
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 86-7446
• Catalog Number: 867446
• 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	10603295218005 [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.

• 10603295494843 - ATTUNE: 2024-09-11 ATTUNE MAKE TO ORDER FB TIBIAL TRAY INSERTER
• 10603295552345 - ACTIS: 2024-09-05 ACTIS MAKE TO ORDER CURVED INSERTER SHAFT
• 10603295498605 - ATTUNE: 2024-09-03 ATTUNE MAKE TO ORDER SHIM 1mm
• 10603295552406 - ATTUNE: 2024-09-03 ATTUNE MAKE TO ORDER DISTAL FEMORAL 2 DEG FLEXION BLOCK
• 10603295552413 - ATTUNE: 2024-09-03 ATTUNE MAKE TO ORDER DISTAL FEMORAL 3 DEG FLEXION BLOCK
• 10603295552475 - ATTUNE: 2024-09-03 ATTUNE MAKE TO ORDER Distal Femoral Jig Augment Left 1mm
• 10603295552482 - ATTUNE: 2024-09-03 ATTUNE MAKE TO ORDER Distal Femoral Jig Augment Right 1mm
• 10603295552499 - ATTUNE: 2024-09-03 ATTUNE MAKE TO ORDER Distal Femoral Jig Augment Left 3mm