LUX Expandable Lumbar Interbody System LE1-00-102208

GUDID 00840493415949

Lumbar Expandable, 10x22x8-12mm, 0 Deg

XENIX MEDICAL LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00840493415949
• NIH Device Record Key: 74556579-e207-477b-a4a4-d951f19b4c1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUX Expandable Lumbar Interbody System
• Version Model Number: LE1-00-102208
• Catalog Number: LE1-00-102208
• 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	00840493415949 [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

Devices Manufactured by XENIX MEDICAL LLC

• 00840493418704 - RIVA Pedicle Screw System: 2026-04-01 CONSTRAINED LORDOTIC ROD, 5.5mm x 110mm
• 00840493418711 - RIVA Pedicle Screw System: 2026-04-01 CONSTRAINED LORDOTIC ROD, 5.5mm x 120mm
• 00840493418728 - RIVA Pedicle Screw System: 2026-04-01 CONSTRAINED LORDOTIC ROD, 5.5mm x 130mm
• 00840493418735 - RIVA Pedicle Screw System: 2026-04-01 CONSTRAINED LORDOTIC ROD, 5.5mm x 140mm
• 00840493418742 - RIVA Pedicle Screw System: 2026-04-01 CONSTRAINED LORDOTIC ROD, 5.5mm x 150mm
• 00840493418759 - RIVA Pedicle Screw System: 2026-04-01 CONSTRAINED LORDOTIC ROD, 6.0mm x 25mm
• 00840493418766 - RIVA Pedicle Screw System: 2026-04-01 CONSTRAINED LORDOTIC ROD, 6.0mm x 30mm
• 00840493418773 - RIVA Pedicle Screw System: 2026-04-01 CONSTRAINED LORDOTIC ROD, 6.0mm x 35mm