302.4002

GUDID 00889024211605

Orthosoft Inc

Robotic surgical navigation system

• Primary Device ID: 00889024211605
• NIH Device Record Key: b4f8cbc8-d33d-44fa-a2e3-c464a22907d2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 302.4002
• Catalog Number: 302.4002
• 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	00889024211605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071714

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-14

Devices Manufactured by Orthosoft Inc

• 00887868578915 - HAMMR™: 2024-05-01
• 00887868557873 - ROSA® Shoulder: 2024-03-14
• 00887868557880 - ROSA® Shoulder: 2024-03-14
• 00887868557897 - ROSA® Shoulder: 2024-03-14
• 00887868557903 - ROSA® Shoulder: 2024-03-14
• 00887868557910 - ROSA® Shoulder: 2024-03-14
• 00887868558078 - ROSA® Shoulder: 2024-03-14
• 00887868558092 - ROSA® Shoulder: 2024-03-14