FDA.reportPublic FDA data

LUX Expandable Interbody System

Primary DI
00840493416526
Brand
LUX Expandable Interbody System
Company
XENIX MEDICAL LLC
Model
LE1-A4-000550
Catalog number
LE1-A4-000550
Device description
Luer to M8 Adapter
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253583000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253583000LUX Expandable Lumbar Interbody SystemXenix Medical2026-02-23MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840493416526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493416526008404934165268404934165260840493416526

GMDN Terms#

Term, Definition table
TermDefinition
Luer/non-ISO80369-standardized linear connector, reusableA small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, bayonet, collet, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing or an external puncturing component. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080386764
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493425559RIVA Pedicle Screw SystemFG1-15-300600FG1-15-3006002026-08-03
00840493425566RIVA Pedicle Screw SystemFG1-16-300025FG1-16-3000252026-08-03
00840493425573RIVA Pedicle Screw SystemFG1-16-300030FG1-16-3000302026-08-03
00840493425580RIVA Pedicle Screw SystemFG1-16-300035FG1-16-3000352026-08-03
00840493425597RIVA Pedicle Screw SystemFG1-16-300040FG1-16-3000402026-08-03
00840493425603RIVA Pedicle Screw SystemFG1-16-300045FG1-16-3000452026-08-03
00840493425610RIVA Pedicle Screw SystemFG1-16-300050FG1-16-3000502026-08-03
00840493425627RIVA Pedicle Screw SystemFG1-16-300055FG1-16-3000552026-08-03
00840493425634RIVA Pedicle Screw SystemFG1-16-300060FG1-16-3000602026-08-03
00840493425641RIVA Pedicle Screw SystemFG1-16-300065FG1-16-3000652026-08-03
00840493425658RIVA Pedicle Screw SystemFG1-16-300070FG1-16-3000702026-08-03
00840493425665RIVA Pedicle Screw SystemFG1-16-300075FG1-16-3000752026-08-03
00840493425672RIVA Pedicle Screw SystemFG1-16-300080FG1-16-3000802026-08-03
00840493425689RIVA Pedicle Screw SystemFG1-16-300085FG1-16-3000852026-08-03
00840493425696RIVA Pedicle Screw SystemFG1-16-300090FG1-16-3000902026-08-03
00840493425702RIVA Pedicle Screw SystemFG1-16-300095FG1-16-3000952026-08-03
00840493425719RIVA Pedicle Screw SystemFG1-16-300100FG1-16-3001002026-08-03
00840493425726RIVA Pedicle Screw SystemFG1-16-300110FG1-16-3001102026-08-03
00840493425382RIVA Pedicle Screw SystemFG1-15-300085FG1-15-3000852026-07-28
00840493425399RIVA Pedicle Screw SystemFG1-15-300090FG1-15-3000902026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841523183081Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523183746Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185030Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185047Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185054Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185061Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185078Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185092Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185108Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185139Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185146Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185153Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185160Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185177Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185382Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
B382SD484620Surgical DirectSurgical Direct, Inc.LXH2026-08-07
M7409200004MIS TLIF SystemSPINEOLOGY INC.LXH2026-08-07
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31