BluEX Lumbar Expandable Cage System— 510(k) K242829

Clearance details

Applicant

L&K BIOMED Co., Ltd.

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2024-09-19

Decision date

2024-10-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Yongin-Si, KR

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• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K262489 — BluEX Cervical Expandable Cage System2026-08-18
• K260840 — BluEX Cervical Expandable Cage System2026-05-16
• K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
• K261130 — AccelFix Spinal Fixation System2026-05-05
• K260448 — CastleLoc Pectus Bar System2026-03-19

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →