FDA.reportPublic FDA data

BluEX-TM Lumbar Interbody Fusion Cage System

Primary DI
08809986488930
Brand
BluEX-TM Lumbar Interbody Fusion Cage System
Company
L&K BIOMED CO. ,LTD.
Model
JPT2211-0700S
Device description
BluEX-TM (22 X 11 X 7 mm, 0°)
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
08809986488930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809986488930088099864889308809986488930

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
08809986479907LnK Spinal Instrument SystemCM0141-CC022026-05-12
08809986479914LnK Spinal Instrument SystemCM146-CS02-03012026-05-12
08809986479921LnK Spinal Instrument SystemCM146-CS02-03022026-05-12
08809986469991LnK Spinal Instrument SystemCM0142-PT012026-04-30
08809986489296LnK Spinal Instrument SystemLP01-07022026-04-29
08809986489302LnK Spinal Instrument SystemLP01-07042026-04-29
08809986489319LnK Spinal Instrument SystemLP01-07052026-04-29
08806344399808LnK Spinal Instrument SystemLS03-CM612026-04-16
08809986482815CastleLoc Pectus Bar SystemOB28-01102026-04-17
08809986482822CastleLoc Pectus Bar SystemOB28-01152026-04-17
08809986482839CastleLoc Pectus Bar SystemOB28-01202026-04-17
08809986482846CastleLoc Pectus Bar SystemOB28-01252026-04-17
08809986482853CastleLoc Pectus Bar SystemOB28-01302026-04-17
08809986482860CastleLoc Pectus Bar SystemOB28-01352026-04-17
08809986469878LnK Spinal Instrument SystemBR05-00082026-04-16
08809986469885LnK Spinal Instrument SystemBR05-00092026-04-16
08809986479860LnK Spinal Instrument SystemBT01-90012026-04-16
08809986479877LnK Spinal Instrument SystemBT01-90022026-04-16
08809986479884LnK Spinal Instrument SystemBT01-90032026-04-16
08809986479891LnK Spinal Instrument SystemBT01-90042026-04-16

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