Streamline TL Spinal Fixation System

GUDID 00840311258055

T-HANDLE

Xtant Medical Holdings, Inc.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00840311258055
• NIH Device Record Key: cd5f3e20-702f-4a0b-8eff-b278cc8e414f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline TL Spinal Fixation System
• Version Model Number: 10-THANDLE
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311258055 [Primary]
GS1	00846468001780 [Previous]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840311258055]

Moist Heat or Steam Sterilization

[00840311258055]

Moist Heat or Steam Sterilization

[00840311258055]

Moist Heat or Steam Sterilization

[00840311258055]

Moist Heat or Steam Sterilization

[00840311258055]

Moist Heat or Steam Sterilization

[00840311258055]

Moist Heat or Steam Sterilization

[00840311258055]

Moist Heat or Steam Sterilization

[00840311258055]

Moist Heat or Steam Sterilization

[00840311258055]

Moist Heat or Steam Sterilization

[00840311258055]

Moist Heat or Steam Sterilization

[00840311258055]

Moist Heat or Steam Sterilization

[00840311258055]

Moist Heat or Steam Sterilization

[00840311258055]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-06
• Device Publish Date: 2025-09-26

On-Brand Devices [Streamline TL Spinal Fixation System]

• 00840311257935: T-HANDLE, RATCHETING
• 00840311257942: ROD TEMPLATE
• 00840311258055: T-HANDLE