CUVIS-spine CA-00000-000

GUDID 08800043830013

CUREXO, Inc.

Robotic surgical navigation system

• Primary Device ID: 08800043830013
• NIH Device Record Key: 4cf83ade-6dfb-4064-bb0f-100bed51bf01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CUVIS-spine
• Version Model Number: CS100
• Catalog Number: CA-00000-000
• Company DUNS: 688003227
• Company Name: CUREXO, 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: false
• Serial Number: true
• 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: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com
• Phone: +82317887933
• Email: jkoh@curexo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800043830013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222698

FDA Product Code

• OLO: Orthopedic 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: 2
• Public Version Date: 2023-09-27
• Device Publish Date: 2022-12-28

On-Brand Devices [CUVIS-spine]

• 08800043830020: CS200
• 08800043830013: CS100