Persona® 20-8070-001-02

GUDID 00889024305595

Orthosoft Inc

Orthopaedic implant aiming arm

• Primary Device ID: 00889024305595
• NIH Device Record Key: 272194f2-a7dd-4503-8920-fc6a3bee4c5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Persona®
• Version Model Number: 20-8070-001-02
• Catalog Number: 20-8070-001-02
• Company DUNS: 205670032
• Company Name: Orthosoft 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: false
• 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@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024305595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131409

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00889024305595]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2017-09-28

On-Brand Devices [Persona®]

• 00889024305786: 20-8070-011-02
• 00889024305779: 20-8070-011-01
• 00889024305762: 20-8070-010-02
• 00889024305755: 20-8070-010-01
• 00889024305618: 20-8070-002-02
• 00889024305601: 20-8070-002-01
• 00889024305595: 20-8070-001-02
• 00889024305588: 20-8070-001-01