00-5224-034-07

GUDID 00889024188136

Zimmer, Inc.

Tibial insert

• Primary Device ID: 00889024188136
• NIH Device Record Key: 52bea4f4-d271-4aba-b51f-48c563be8ae9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5224-34-07
• Catalog Number: 00-5224-034-07
• 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	00889024188136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872379

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: 4
• Public Version Date: 2019-07-31
• Device Publish Date: 2017-10-20

Devices Manufactured by Zimmer, Inc.

• 00887868582028 - Affixus®: 2024-10-25
• 00887868582035 - Affixus®: 2024-10-25
• 00887868582042 - Affixus®: 2024-10-25
• 00887868582059 - Affixus®: 2024-10-25
• 00887868582066 - Affixus®: 2024-10-25
• 00887868582073 - Affixus®: 2024-10-25
• 00887868582080 - Affixus®: 2024-10-25
• 00887868582097 - Affixus®: 2024-10-25