LUX Expandable Interbody System LE1-A3-001140

GUDID 00840493416458

Offset Handle

XENIX MEDICAL LLC

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00840493416458
• NIH Device Record Key: 518682db-cd04-444f-b1e5-9e823472ceb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUX Expandable Interbody System
• Version Model Number: LE1-A3-001140
• Catalog Number: LE1-A3-001140
• Company DUNS: 080386764
• Company Name: XENIX MEDICAL LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840493416458 [Primary]

FDA Product Code

• LYQ: Accessories, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840493416458]

Moist Heat or Steam Sterilization

[00840493416458]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-03
• Device Publish Date: 2026-02-23

On-Brand Devices [LUX Expandable Interbody System]

• 00840493416533: Driver Adapter
• 00840493416519: Cartridge Base
• 00840493416502: Plunger
• 00840493416496: Graft Funnel
• 00840493416489: Graft Cartridge
• 00840493416465: Expansion Driver
• 00840493416458: Offset Handle
• 00840493416441: Expandable Inserter