BluEX Lumbar Expandable Cage System

GUDID 08809986462084

BluEX-T (11 X 25 X 11 mm, 20°)

L&K BIOMED CO. ,LTD.

Metallic spinal interbody fusion cage
Primary Device ID08809986462084
NIH Device Record Keyd6500f34-91c4-410d-a7d5-1be62bc535da
Commercial Distribution StatusIn Commercial Distribution
Brand NameBluEX Lumbar Expandable Cage System
Version Model NumberBT2511-1120S
Company DUNS631159324
Company NameL&K BIOMED CO. ,LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809986462084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-27
Device Publish Date2025-03-19

On-Brand Devices [BluEX Lumbar Expandable Cage System]

08809986461759BluEX-T (11 X 22 X 11 mm, 0°)
08809986461742BluEX-T (11 X 22 X 09 mm, 0°)
08809986461735BluEX-T (11 X 22 X 07 mm, 0°)
08809986462176BluEX-TC (11 X 22 X 11 mm, 8°)
08809986462169BluEX-TC (11 X 22 X 09 mm, 8°)
08809986462152BluEX-TC (11 X 22 X 07 mm, 8°)
08809986462145BluEX-TC (11 X 22 X 11 mm, 4°)
08809986462138BluEX-TC (11 X 22 X 09 mm, 4°)
08809986462121BluEX-TC (11 X 22 X 07 mm, 4°)
08809986462114BluEX-TC (11 X 22 X 11 mm, 0°)
08809986462107BluEX-TC (11 X 22 X 09 mm, 0°)
08809986462091BluEX-TC (11 X 22 X 07 mm, 0°)
08809986462084BluEX-T (11 X 25 X 11 mm, 20°)
08809986462077BluEX-T (11 X 25 X 09 mm, 20°)
08809986462060BluEX-T (11 X 25 X 07 mm, 20°)
08809986462053BluEX-T (11 X 25 X 11 mm, 15°)
08809986462046BluEX-T (11 X 25 X 09 mm, 15°)
08809986462039BluEX-T (11 X 25 X 07 mm, 15°)
08809986462022BluEX-T (11 X 25 X 11 mm, 12°)
08809986462015BluEX-T (11 X 25 X 09 mm, 12°)
08809986462008BluEX-T (11 X 25 X 07 mm, 12°)
08809986461995BluEX-T (11 X 25 X 11 mm, 8°)
08809986461988BluEX-T (11 X 25 X 09 mm, 8°)
08809986461971BluEX-T (11 X 25 X 07 mm, 8°)
08809986461964BluEX-T (11 X 25 X 11 mm, 4°)
08809986461957BluEX-T (11 X 25 X 09 mm, 4°)
08809986461940BluEX-T (11 X 25 X 07 mm, 4°)
08809986461933BluEX-T (11 X 25 X 11 mm, 0°)
08809986461926BluEX-T (11 X 25 X 09 mm, 0°)
08809986461919BluEX-T (11 X 25 X 07 mm, 0°)
08809986461902BluEX-T (11 X 22 X 11 mm, 20°)
08809986461896BluEX-T (11 X 22 X 09 mm, 20°)
08809986461889BluEX-T (11 X 22 X 07 mm, 20°)
08809986461872BluEX-T (11 X 22 X 11 mm, 15°)
08809986461865BluEX-T (11 X 22 X 09 mm, 15°)
08809986461858BluEX-T (11 X 22 X 07 mm, 15°)
08809986461841BluEX-T (11 X 22 X 11 mm, 12°)
08809986461834BluEX-T (11 X 22 X 09 mm, 12°)
08809986461827BluEX-T (11 X 22 X 07 mm, 12°)
08809986461810BluEX-T (11 X 22 X 11 mm, 8°)
08809986461803BluEX-T (11 X 22 X 09 mm, 8°)
08809986461797BluEX-T (11 X 22 X 07 mm, 8°)
08809986461780BluEX-T (11 X 22 X 11 mm, 4°)
08809986461773BluEX-T (11 X 22 X 09 mm, 4°)
08809986461766BluEX-T (11 X 22 X 07 mm, 4°)
08809986462800BluEX-ATP (18 X 55 X 13 mm, 12°)
08809986462794BluEX-ATP (18 X 55 X 11 mm, 12°)
08809986462787BluEX-ATP (18 X 55 X 09 mm, 12°)
08809986462770BluEX-ATP (18 X 55 X 11 mm, 6°)
08809986462763BluEX-ATP (18 X 55 X 09 mm, 6°)

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