00-5220-035-07

GUDID 00889024582712

Zimmer, Inc.

Tibial insert

• Primary Device ID: 00889024582712
• NIH Device Record Key: 89ec0522-9f63-440a-a902-2a4e4f7e6748
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5220-35-07
• Catalog Number: 00-5220-035-07
• 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	00889024582712 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-19
• Device Publish Date: 2019-08-09

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• 00889024658165 - Persona® Knee System: 2025-02-14
• 00889024658172 - Persona® Knee System: 2025-02-14
• 00889024658189 - Persona® Knee System: 2025-02-14
• 00889024658196 - Persona® Knee System: 2025-02-14
• 00889024658202 - Persona® Knee System: 2025-02-14