FDA.reportPublic FDA data

LUX Expandable Interbody System

Primary DI
00840493416687
Brand
LUX Expandable Interbody System
Company
XENIX MEDICAL LLC
Model
LE1-T2-004008
Catalog number
LE1-T2-004008
Device description
Trial, 8mm
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

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
00840493416687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493416687008404934166878404934166870840493416687

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. 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
00840493441634RIVA Pedicle Screw SystemFG1-A3-021922FG1-A3-0219222026-10-05
00840493441641LUX Expandable Interbody SystemLE1-A4-000560LE1-A4-0005602026-10-05
00840493441658LUX Expandable Interbody SystemLE1-A4-000570LE1-A4-0005702026-10-05
00840493441665RIVA Pedicle Screw SystemFG1-A1-000063FG1-A1-0000632026-10-05
00840493441672RIVA Pedicle Screw SystemFG1-A3-000081FG1-A3-0000812026-10-05
00840493441689RIVA Pedicle Screw SystemFG1-A3-000040FG1-A3-0000402026-10-05
00840493441696RIVA Pedicle Screw SystemFG1-A5-000013FG1-A5-0000132026-10-05
00840493441719RIVA Pedicle Screw SystemFG1-A1-000064FG1-A1-0000642026-10-05
00840493442020Xenix Medical Universal HandleUN1-H0-423005UN1-H0-4230052026-10-05
00840493442037Xenix Medical Universal HandleUN1-H0-423006UN1-H0-4230062026-10-05
00840493426426RIVA Pedicle Screw SystemFG1-16-302065FG1-16-3020652026-08-18
00840493426433RIVA Pedicle Screw SystemFG1-16-302070FG1-16-3020702026-08-18
00840493426440RIVA Pedicle Screw SystemFG1-16-302075FG1-16-3020752026-08-18
00840493426457RIVA Pedicle Screw SystemFG1-16-302080FG1-16-3020802026-08-18
00840493426464RIVA Pedicle Screw SystemFG1-16-302085FG1-16-3020852026-08-18
00840493426471RIVA Pedicle Screw SystemFG1-16-302090FG1-16-3020902026-08-18
00840493426488RIVA Pedicle Screw SystemFG1-16-302095FG1-16-3020952026-08-18
00840493426495RIVA Pedicle Screw SystemFG1-16-302100FG1-16-3021002026-08-18
00840493426501RIVA Pedicle Screw SystemFG1-16-302110FG1-16-3021102026-08-18
00840493426518RIVA Pedicle Screw SystemFG1-16-302120FG1-16-3021202026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B678522201S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522202S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522203S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522204S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522205S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522206S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
00810017913763Saber-C Body (PT), 14x15x5 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913961Saber-C Body (PT), 14x17x7 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913978Saber-C Body (PT), 14x17x8 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913985Saber-C Body (PT), 14x17x9 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913992Saber-C Body (PT), 14x17x10 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914005Saber-C Body (PT), 15x18x5 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914012Saber-C Body (PT), 15x18x6 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914029Saber-C Body (PT), 15x18x7 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914036Saber-C Body (PT), 15x18x8 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914043Saber-C Body (PT), 15x18x9 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914050Saber-C Body (PT), 15x18x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914425Saber-C Body (PT), 14x15x6 12 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914432Saber-C Body (PT), 14x15x7 12 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914449Saber-C Body (PT), 14x15x8 12 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914456Saber-C Body (PT), 14x15x9 12 deg.ELEVATION SPINE, INC.ODP2026-10-26