BluEX Lumbar Expandable Cage System

GUDID 08809986461995

BluEX-T (11 X 25 X 11 mm, 8°)

L&K BIOMED CO. ,LTD.

Metallic spinal interbody fusion cage
Primary Device ID08809986461995
NIH Device Record Key4f94566a-4fa0-4456-a680-46a57d910e07
Commercial Distribution StatusIn Commercial Distribution
Brand NameBluEX Lumbar Expandable Cage System
Version Model NumberBT2511-1108S
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
GS108809986461995 [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°)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.