FDA.reportPublic FDA data

BluEX-TM Lumbar Interbody Fusion Cage System

Primary DI
08809986489067
Brand
BluEX-TM Lumbar Interbody Fusion Cage System
Company
L&K BIOMED CO. ,LTD.
Model
JPT2211-0915S
Device description
BluEX-TM (22 X 11 X 9 mm, 15°)
Published
2026-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K251741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251741000PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.2025-07-08MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809986489067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809986489067088099864890678809986489067

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.

Regulatory Flags#

DUNS number
631159324
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986482440CastleLoc Pectus Bar SystemPF12-20222026-08-25
08809986482457CastleLoc Pectus Bar SystemPF12-23122026-08-25
08809986482464CastleLoc Pectus Bar SystemPF12-23152026-08-25
08809986482471CastleLoc Pectus Bar SystemPF12-23182026-08-25
08809986482488CastleLoc Pectus Bar SystemPF12-23222026-08-25
08809986482495CastleLoc Pectus Bar SystemPF12-25182026-08-25
08809986481894CastleLoc Pectus Bar SystemPB25-E1602026-08-21
08809986481900CastleLoc Pectus Bar SystemPB25-E1652026-08-21
08809986481917CastleLoc Pectus Bar SystemPB25-E1702026-08-21
08809986481924CastleLoc Pectus Bar SystemPB10-00032026-08-21
08809986481931CastleLoc Pectus Bar SystemPB10-00072026-08-21
08809986481948CastleLoc Pectus Bar SystemPB10-00082026-08-21
08809986481955CastleLoc Pectus Bar SystemPB10-00092026-08-21
08809986481962CastleLoc Pectus Bar SystemPB10-00102026-08-21
08809986481979CastleLoc Pectus Bar SystemPB10-00112026-08-21
08809986481986CastleLoc Pectus Bar SystemPB10-00122026-08-21
08809986481993CastleLoc Pectus Bar SystemPB10-00132026-08-21
08809986482006CastleLoc Pectus Bar SystemPB10-00142026-08-21
08809986482013CastleLoc Pectus Bar SystemPB10-00152026-08-21
08809986482020CastleLoc Pectus Bar SystemPB10-00162026-08-21

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Primary DI, Brand, Company table
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