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FDA 510(k)

BluEX Cervical Expandable Cage System

K-Number: K260840 · 2026-05-16

ApplicantL&K BIOMED Co., Ltd.
Decision Date2026-05-16
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BluEX Cervical Expandable Cage System is the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2026-05-16 under 510(k) number K260840. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BluEX Cervical Expandable Cage System?

BluEX Cervical Expandable Cage System is a medical device that received FDA 510(k) clearance on 2026-05-16. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K260840.

When did BluEX Cervical Expandable Cage System receive FDA 510(k) clearance?

BluEX Cervical Expandable Cage System received FDA 510(k) clearance on 2026-05-16, under 510(k) number K260840.

Who is the listed applicant for BluEX Cervical Expandable Cage System?

The FDA 510(k) record lists L&K BIOMED Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for BluEX Cervical Expandable Cage System is ODP.

Other records listing L&K BIOMED Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261112CastleLoc-P Anterior Cervical Plate SystemK261130AccelFix Spinal Fixation SystemK260448CastleLoc Pectus Bar SystemK251940PathLoc Lumbar Plate SystemK251741PathLoc Lumbar Interbody Fusion Cage SystemK250892CastleLoc Pectus Bar System

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Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.K253260ORIO-3D Cage SystemSpineCraft

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.

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