Persona 20-8014-015-00

GUDID 00889024305571

Orthosoft Inc

Orthopaedic implant aiming arm

• Primary Device ID: 00889024305571
• NIH Device Record Key: bb3c5cc4-f4d4-48ed-99a1-6cba7d2e2d64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Persona
• Version Model Number: 20-8014-015-00
• Catalog Number: 20-8014-015-00
• 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: false
• 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	00889024305571 [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

[00889024305571]

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: 2016-09-07

On-Brand Devices [Persona]

• 00889024304116: 20-8000-010-67
• 00889024304109: 20-8000-010-65
• 00889024304093: 20-8000-010-63
• 00889024304086: 20-8000-010-61
• 00889024305571: 20-8014-015-00