iASSIST® Knee System 302.4021

GUDID 00887868558467

Orthosoft Inc

Robotic surgical navigation system

• Primary Device ID: 00887868558467
• NIH Device Record Key: b2990a29-af7a-4a77-9d4f-2cc466a4b119
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iASSIST® Knee System
• Version Model Number: 302.4021
• Catalog Number: 302.4021
• 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: true
• 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@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	00887868558467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213033

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00887868558467]

Moist Heat or Steam Sterilization

[00887868558467]

Moist Heat or Steam Sterilization

[00887868558467]

Moist Heat or Steam Sterilization

[00887868558467]

Moist Heat or Steam Sterilization

[00887868558467]

Moist Heat or Steam Sterilization

[00887868558467]

Moist Heat or Steam Sterilization

[00887868558467]

Moist Heat or Steam Sterilization

[00887868558467]

Moist Heat or Steam Sterilization

[00887868558467]

Moist Heat or Steam Sterilization

[00887868558467]

Moist Heat or Steam Sterilization

[00887868558467]

Moist Heat or Steam Sterilization

[00887868558467]

Moist Heat or Steam Sterilization

[00887868558467]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-29
• Device Publish Date: 2022-09-21

On-Brand Devices [iASSIST® Knee System]

• 00887868558474: 20-8011-900-13
• 00887868558467: 302.4021
• 00887868519161: 20-8011-065-00
• 00887868519154: 20-8011-063-00
• 00887868519147: 20-8000-070-03
• 00887868519130: 20-8000-070-02
• 00887868519017: 20-8011-501-00