N/A CA-00000-000

GUDID 08800043830006

CUREXO, Inc.

Robotic surgical navigation system

• Primary Device ID: 08800043830006
• NIH Device Record Key: 69480ca4-87c8-46c4-9da5-365f6b811e02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: CUVIS-spine
• 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
• 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
• 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	08800043830006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201569

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-22
• Device Publish Date: 2021-12-14

Devices Manufactured by CUREXO, Inc.

• 08800043830013 - CUVIS-spine: 2023-09-27
• 08800043830020 - CUVIS-spine: 2023-07-05
• 08800043860768 - CUVIS-spine Drape: 2023-04-25
• 08800043860775 - CUVIS-spine Drape: 2023-04-25
• 08800043860782 - CUVIS-spine Drape: 2023-04-25
• 08800043810022 - Morning Walk: 2021-12-22 MW-S200
• 08800043830006 - N/A: 2021-12-22
• 08800043830006 - N/A: 2021-12-22
• 08800043810121 - Morning Walk: 2020-05-06