FDA 510(k)

BluEX Lumbar Expandable Cage System

K-Number: K242829 · 2024-10-23

Decision Date2024-10-23

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BluEX Lumbar Expandable Cage System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2024-10-23 under approval number K242829. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BluEX Lumbar Expandable Cage System?

BluEX Lumbar Expandable Cage System is a medical device that received FDA 510(k) clearance on 2024-10-23. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K242829.

When was BluEX Lumbar Expandable Cage System approved by the FDA?

BluEX Lumbar Expandable Cage System received FDA 510(k) clearance on 2024-10-23, under approval number K242829.

What company makes BluEX Lumbar Expandable Cage System?

BluEX Lumbar Expandable Cage System is manufactured by L&K BIOMED Co., Ltd..

What is the FDA product code for BluEX Lumbar Expandable Cage System?

The FDA product code for BluEX Lumbar Expandable Cage System is MAX.

Related Clinical Trials

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Other Devices by L&K BIOMED Co., Ltd.

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.