Nexgen, Legacy 20-8070-003-02

GUDID 00889024305632

Orthosoft Inc

Orthopaedic implant aiming arm

• Primary Device ID: 00889024305632
• NIH Device Record Key: fa0412d3-0d30-4c01-a958-cc8ddbb0d41b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexgen, Legacy
• Version Model Number: 20-8070-003-02
• Catalog Number: 20-8070-003-02
• 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	00889024305632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131409

FDA Product Code

• OOG: Knee Arthroplasty Implantation System

Sterilization

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

[00889024305632]

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 [Nexgen, Legacy]

• 00889024305670: 20-8070-005-02
• 00889024305663: 20-8070-005-01
• 00889024305656: 20-8070-004-02
• 00889024305649: 20-8070-004-01
• 00889024305632: 20-8070-003-02
• 00889024305625: 20-8070-003-01