Cleared Traditional

BluEX Lumbar Expandable Cage System

K242829 · L & K Biomed Co., Ltd. · Orthopedic

Oct 2024

Decision

34d

Days

Class 2

Risk

About This 510(k) Submission

K242829 is an FDA 510(k) clearance for the BluEX Lumbar Expandable Cage System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on October 23, 2024, 34 days after receiving the submission on September 19, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K242829 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 2024
Decision Date	October 23, 2024
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.