Romero Large Introducer for Standard Heights RO0005LISH

GUDID B806RO0005LISH0

Romero Large Introducer for Standard Heights (H is less than 10)

Spineup, Inc.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: B806RO0005LISH0
• NIH Device Record Key: 5cfa8426-ec94-4a5f-9b3e-dd99f858215e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Romero Large Introducer for Standard Heights
• Version Model Number: RO0005LISH
• Catalog Number: RO0005LISH
• 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: false
• 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: 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
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B806RO0005LISH0 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

[B806RO0005LISH0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-22
• Device Publish Date: 2024-10-14

Devices Manufactured by Spineup, Inc.

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• B806ISRO1214A07CB10 - ROMERO CERVICAL CAGE, W14xD12xH07: 2025-12-11 The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers
• B806ISRO1214A08CB10 - ROMERO CERVICAL CAGE, W14xD12xH08: 2025-12-11 The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers