PERSONA™ Trabecular Metal™ 42-5022-066-01

GUDID 00889024470118

Zimmer, Inc.

Coated knee femur prosthesis

• Primary Device ID: 00889024470118
• NIH Device Record Key: 3eaa5715-0364-43bd-aa64-04bcc629ffbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERSONA™ Trabecular Metal™
• Version Model Number: 42-5022-066-01
• Catalog Number: 42-5022-066-01
• 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
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024470118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122745

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: 2019-11-14
• Device Publish Date: 2017-08-24

On-Brand Devices [PERSONA™ Trabecular Metal™]

• 00889024470163: 42-5022-070-02
• 00889024470156: 42-5022-070-01
• 00889024470149: 42-5022-068-02
• 00889024470132: 42-5022-068-01
• 00889024470125: 42-5022-066-02
• 00889024470118: 42-5022-066-01
• 00889024470101: 42-5022-064-02
• 00889024470095: 42-5022-064-01
• 00889024470088: 42-5022-062-02
• 00889024470071: 42-5022-062-01
• 00889024470064: 42-5022-060-02
• 00889024470057: 42-5022-060-01
• 00889024470040: 42-5022-058-02
• 00889024470033: 42-5022-058-01
• 00889024230842: 42-5028-070-02
• 00889024230835: 42-5028-070-01
• 00889024230828: 42-5028-068-02
• 00889024230811: 42-5028-068-01
• 00889024230804: 42-5028-066-02
• 00889024230798: 42-5028-066-01
• 00889024230781: 42-5028-064-02
• 00889024230774: 42-5028-064-01
• 00889024230767: 42-5028-062-02
• 00889024230750: 42-5028-062-01
• 00889024230743: 42-5028-060-02
• 00889024230736: 42-5028-060-01
• 00889024230729: 42-5028-058-02
• 00889024230712: 42-5028-058-01
• 00889024230088: 42-5022-052-02
• 00889024230071: 42-5022-052-01
• 00889024230064: 42-5022-050-02
• 00889024230057: 42-5022-050-01
• 00889024232877: 42-5099-092-10
• 00889024230866: 42-5028-074-02
• 00889024230859: 42-5028-074-01
• 00889024230705: 42-5028-056-02
• 00889024230699: 42-5028-056-01
• 00889024230682: 42-5028-054-02
• 00889024230675: 42-5028-054-01
• 00889024230262: 42-5022-070-02
• 00889024230255: 42-5022-070-01
• 00889024230248: 42-5022-068-02
• 00889024230231: 42-5022-068-01
• 00889024230224: 42-5022-066-02
• 00889024230217: 42-5022-066-01
• 00889024230200: 42-5022-064-02
• 00889024230194: 42-5022-064-01
• 00889024230187: 42-5022-062-02
• 00889024230170: 42-5022-062-01
• 00889024230163: 42-5022-060-02