LUX Expandable Interbody System LE1-00-102508

GUDID 00840493415963

Lumbar Expandable, 10x25x8-12mm, 0 Deg

XENIX MEDICAL LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00840493415963
• NIH Device Record Key: a7a9a134-40ee-48e4-b7e1-c57d31ff08f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUX Expandable Interbody System
• Version Model Number: LE1-00-102508
• Catalog Number: LE1-00-102508
• Company DUNS: 080386764
• Company Name: XENIX MEDICAL LLC
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840493415963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253583

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-23
• Device Publish Date: 2026-03-13

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
• 00840493416700: Trial, 12mm
• 00840493416694: Trial, 10mm
• 00840493416687: Trial, 8mm
• 00840493416588: Implant Extractor
• 00840493416564: Graft Auger
• 00840493416540: Wrench
• 00840493416526: Luer to M8 Adapter
• 00840493416175: Lumbar Expandable, 12x25x12-16mm, 15 Deg
• 00840493416168: Lumbar Expandable, 12x25x12-16mm, 8 Deg
• 00840493416151: Lumbar Expandable, 12x22x12-16mm, 15 Deg
• 00840493416144: Lumbar Expandable, 12x22x12-16mm, 8 Deg
• 00840493416137: Lumbar Expandable, 12x25x10-14mm, 15 Deg
• 00840493416120: Lumbar Expandable, 12x25x10-14mm, 8 Deg
• 00840493416113: Lumbar Expandable, 12x22x10-14mm, 15 Deg
• 00840493416106: Lumbar Expandable, 12x22x10-14mm, 8 Deg
• 00840493416090: Lumbar Expandable, 12x25x8-12mm, 8 Deg
• 00840493416083: Lumbar Expandable, 12x25x8-12mm, 0 Deg
• 00840493416076: Lumbar Expandable, 12x22x8-12mm, 8 Deg
• 00840493416069: Lumbar Expandable, 12x22x8-12mm, 0 Deg
• 00840493416052: Lumbar Expandable, 10x25x12-16mm, 15 Deg
• 00840493416045: Lumbar Expandable, 10x25x12-16mm, 8 Deg
• 00840493416038: Lumbar Expandable, 10x22x12-16mm, 15 Deg
• 00840493416021: Lumbar Expandable, 10x22x12-16mm, 8 Deg
• 00840493416014: Lumbar Expandable, 10x25x10-14mm, 15 Deg
• 00840493416007: Lumbar Expandable, 10x25x10-14mm, 8 Deg
• 00840493415994: Lumbar Expandable, 10x22x10-14mm, 15 Deg
• 00840493415987: Lumbar Expandable, 10x22x10-14mm, 8 Deg
• 00840493415970: Lumbar Expandable, 10x25x8-12mm, 8 Deg
• 00840493415963: Lumbar Expandable, 10x25x8-12mm, 0 Deg
• 00840493415956: Lumbar Expandable, 10x22x8-12mm, 8 Deg