BluEX Lumbar Expandable Cage System

GUDID 08809986462343

BluEX-TC (11 X 25 X 09 mm, 8°)

L&K BIOMED CO. ,LTD.

Metallic spinal interbody fusion cage

• Primary Device ID: 08809986462343
• NIH Device Record Key: d5ebbb36-233a-4b6a-ab39-027565ff0c25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BluEX Lumbar Expandable Cage System
• Version Model Number: BC2511-0908S
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809986462343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242829

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [BluEX Lumbar Expandable Cage System]

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