N/A CA-00000-000

GUDID 08800043830006

CUREXO, Inc.

Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system 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