LUX Expandable Interbody System LE1-A4-000540

GUDID 00840493416519

Cartridge Base

XENIX MEDICAL LLC

Bone graft funnel
Primary Device ID00840493416519
NIH Device Record Key5e9ae771-ad37-4274-94b4-7bfd536070c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUX Expandable Interbody System
Version Model NumberLE1-A4-000540
Catalog NumberLE1-A4-000540
Company DUNS080386764
Company NameXENIX MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840493416519 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840493416519]

Moist Heat or Steam Sterilization


[00840493416519]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-03
Device Publish Date2026-02-23

On-Brand Devices [LUX Expandable Interbody System]

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

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