BluEX Lumbar Expandable Cage System

GUDID 08809986461933

BluEX-T (11 X 25 X 11 mm, 0°)

L&K BIOMED CO. ,LTD.

Metallic spinal interbody fusion cage
Primary Device ID08809986461933
NIH Device Record Keyd562921f-0975-4e70-be63-01bb3f3c6d8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBluEX Lumbar Expandable Cage System
Version Model NumberBT2511-1100S
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
GS108809986461933 [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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