Persona® The Personalized Knee® OsseoTi® 42-5350-067-02

GUDID 00889024631915

Zimmer, Inc.

Coated knee tibia prosthesis

• Primary Device ID: 00889024631915
• NIH Device Record Key: 4fd209c4-5cea-4240-a7b1-b3ec0eb293f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Persona® The Personalized Knee® OsseoTi®
• Version Model Number: 42-5350-067-02
• Catalog Number: 42-5350-067-02
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024631915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221479

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, 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: 2022-12-01
• Device Publish Date: 2022-11-23

On-Brand Devices [Persona® The Personalized Knee® OsseoTi®]

• 00889024632011: 42-5350-088-02
• 00889024632004: 42-5350-088-01
• 00889024631991: 42-5350-083-02
• 00889024631984: 42-5350-083-01
• 00889024631977: 42-5350-079-02
• 00889024631960: 42-5350-079-01
• 00889024631953: 42-5350-075-02
• 00889024631946: 42-5350-075-01
• 00889024631939: 42-5350-071-02
• 00889024631922: 42-5350-071-01
• 00889024631915: 42-5350-067-02
• 00889024631908: 42-5350-067-01
• 00889024631892: 42-5350-064-02
• 00889024631885: 42-5350-064-01
• 00889024631878: 42-5350-061-02
• 00889024631861: 42-5350-061-01
• 00889024631854: 42-5350-058-02
• 00889024631847: 42-5350-058-01
• 00889024646414: 42-5405-000-41
• 00889024646407: 42-5405-000-38
• 00889024646391: 42-5405-000-35
• 00889024646384: 42-5405-000-32
• 00889024646377: 42-5405-000-29