FDA.reportPublic FDA data

LUX Expandable Interbody System

Primary DI
00840493416052
Brand
LUX Expandable Interbody System
Company
XENIX MEDICAL LLC
Model
LE1-15-102512
Catalog number
LE1-15-102512
Device description
Lumbar Expandable, 10x25x12-16mm, 15 Deg
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

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
00840493416052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493416052008404934160528404934160520840493416052

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080386764
Device count
1
Lot or batch
true
Expiration date on label
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
00843511102586Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102593Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102609Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102616Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102623Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102630Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102647Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102654Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102661Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102678Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102685Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102692Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102708Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102715Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102722Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102739Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102746Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102753Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102760Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102777Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102784Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102791Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102807Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102814Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102821Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102838Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102845Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00810166521604X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521611X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521765X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30