BluEX Cervical Expandable Cage System— 510(k) K262489

Name: FDA 510(k) clearance K262489
Creator: U.S. Food and Drug Administration
Published: 2026-08-18

Substantially Equivalent

L&K BIOMED Co., Ltd.

FDA 510(k) clearance K262489 for BluEX Cervical Expandable Cage System, Substantially Equivalent on 2026-08-18. Applicant: L&K BIOMED Co., Ltd.. Device class: 2.

Clearance details

Applicant: L&K BIOMED Co., Ltd.
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2026-07-20
Decision date: 2026-08-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

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K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08
K260840 — BluEX Cervical Expandable Cage System2026-05-16

More clearances from L&K BIOMED Co., Ltd.

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K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K261130 — AccelFix Spinal Fixation System2026-05-05
K260448 — CastleLoc Pectus Bar System2026-03-19
K251940 — PathLoc Lumbar Plate System2026-03-03
K251741 — PathLoc Lumbar Interbody Fusion Cage System2025-07-08

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.