FDA.reportPublic FDA data

LUX Expandable Interbody System

Primary DI
00840493416632
Brand
LUX Expandable Interbody System
Company
XENIX MEDICAL LLC
Model
LE1-B1-001010
Catalog number
LE1-B1-001010
Device description
Posterior Disc Prep Insert
Published
2026-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840493416632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493416632008404934166328404934166320840493416632

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493422398RIVA Pedicle Screw SystemFG1-16-200030FG1-16-2000302026-06-03
00840493422404RIVA Pedicle Screw SystemFG1-16-200035FG1-16-2000352026-06-03
00840493422411RIVA Pedicle Screw SystemFG1-16-200040FG1-16-2000402026-06-03
00840493422428RIVA Pedicle Screw SystemFG1-16-200045FG1-16-2000452026-06-03
00840493422435RIVA Pedicle Screw SystemFG1-16-200050FG1-16-2000502026-06-03
00840493422442RIVA Pedicle Screw SystemFG1-16-200055FG1-16-2000552026-06-03
00840493422459RIVA Pedicle Screw SystemFG1-16-200060FG1-16-2000602026-06-03
00840493422466RIVA Pedicle Screw SystemFG1-16-200065FG1-16-2000652026-06-03
00840493422473RIVA Pedicle Screw SystemFG1-16-200070FG1-16-2000702026-06-03
00840493422480RIVA Pedicle Screw SystemFG1-16-200075FG1-16-2000752026-06-03
00840493422497RIVA Pedicle Screw SystemFG1-16-200080FG1-16-2000802026-06-03
00840493422503RIVA Pedicle Screw SystemFG1-16-200085FG1-16-2000852026-06-03
00840493422510RIVA Pedicle Screw SystemFG1-16-200090FG1-16-2000902026-06-03
00840493422527RIVA Pedicle Screw SystemFG1-16-200095FG1-16-2000952026-06-03
00840493422534RIVA Pedicle Screw SystemFG1-16-200100FG1-16-2001002026-06-03
00840493422541RIVA Pedicle Screw SystemFG1-16-200110FG1-16-2001102026-06-03
00840493422558RIVA Pedicle Screw SystemFG1-16-200120FG1-16-2001202026-06-03
00840493422565RIVA Pedicle Screw SystemFG1-16-200130FG1-16-2001302026-06-03
00840493422572RIVA Pedicle Screw SystemFG1-16-200140FG1-16-2001402026-06-03
00840493422589RIVA Pedicle Screw SystemFG1-16-200150FG1-16-2001502026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03
07613327605716PANGEAStryker GmbHFSM2026-06-02
07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
07630055307736ACE Acetabular Reamer Tray - Instrument TrayIncipio Devices SAFSM2026-04-30
07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03
ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
07630894802683APTUSMedartis AGFSM2023-02-24
07630894802973APTUSMedartis AGFSM2023-02-24
07630894802980APTUSMedartis AGFSM2023-02-24
07630894802997APTUSMedartis AGFSM2023-02-24
07630894803208APTUSMedartis AGFSM2023-02-24
07630894803215APTUSMedartis AGFSM2023-02-24
07630894803222APTUSMedartis AGFSM2023-02-24
07630894803246APTUSMedartis AGFSM2023-02-24
07630894803260APTUSMedartis AGFSM2023-02-24
07630894803307APTUSMedartis AGFSM2023-02-24
07630894803314APTUSMedartis AGFSM2023-02-24
07630894803321APTUSMedartis AGFSM2023-02-24