ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH12 ISRO1620A12CA1

GUDID B806ISRO1620A12CA10

The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti -6Al-4V ELI) fixation screws for cages with screw holes.

Spineup, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: B806ISRO1620A12CA10
• NIH Device Record Key: ac32b020-a206-46b2-8ff1-87316b5aef8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH12
• Version Model Number: ISRO1620A12CA1
• Catalog Number: ISRO1620A12CA1
• Company DUNS: 116999578
• Company Name: Spineup, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech

Device Dimensions

• Depth: 16 Millimeter
• Angle: 6 degree
• Width: 20 Millimeter
• Height: 12 Millimeter
• Depth: 16 Millimeter
• Angle: 6 degree
• Width: 20 Millimeter
• Height: 12 Millimeter
• Depth: 16 Millimeter
• Angle: 6 degree
• Width: 20 Millimeter
• Height: 12 Millimeter
• Depth: 16 Millimeter
• Angle: 6 degree
• Width: 20 Millimeter
• Height: 12 Millimeter
• Depth: 16 Millimeter
• Angle: 6 degree
• Width: 20 Millimeter
• Height: 12 Millimeter
• Depth: 16 Millimeter
• Angle: 6 degree
• Width: 20 Millimeter
• Height: 12 Millimeter
• Depth: 16 Millimeter
• Angle: 6 degree
• Width: 20 Millimeter
• Height: 12 Millimeter
• Depth: 16 Millimeter
• Angle: 6 degree
• Width: 20 Millimeter
• Height: 12 Millimeter
• Depth: 16 Millimeter
• Angle: 6 degree
• Width: 20 Millimeter
• Height: 12 Millimeter
• Depth: 16 Millimeter
• Angle: 6 degree
• Width: 20 Millimeter
• Height: 12 Millimeter
• Depth: 16 Millimeter
• Angle: 6 degree
• Width: 20 Millimeter
• Height: 12 Millimeter
• Depth: 16 Millimeter
• Angle: 6 degree
• Width: 20 Millimeter
• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B806ISRO1620A12CA10 [Primary]

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-12-12
• Device Publish Date: 2023-10-03

On-Brand Devices [ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH12]

• ISRO1620L12CA1: The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody
• B806ISRO1620L12CA10: The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody
• B806ISRO1620A12CA10: The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody