00-5220-069-00

GUDID 00889024187771

Zimmer, Inc.

Knee femur stem prosthesis

• Primary Device ID: 00889024187771
• NIH Device Record Key: 4145cbd8-c5b8-4a80-9b56-32817c5c5fa3
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5220-69
• Catalog Number: 00-5220-069-00
• Company DUNS: 056038268
• Company Name: Zimmer, 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)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024187771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830121

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-07-01
• Device Publish Date: 2015-10-20

Devices Manufactured by Zimmer, Inc.

• 00889024648180 - ROSA® Shoulder: 2024-02-29
• 00889024648197 - ROSA® Shoulder: 2024-02-29
• 00889024648203 - ROSA® Shoulder: 2024-02-29
• 00889024625877 - G7 25MM DRILL GUIDE: 2023-12-25
• 00889024657441 - RDCTN HNDL ASSY LRG: 2023-12-25
• 00889024658004 - PIVOTING HUMERAL EM GUIDE: 2023-12-25
• 00889024660571 - 3.5MM BALL HEX SHAFT: 2023-12-25
• 00889024661257 - REAMER ADPT PULLER: 2023-12-25