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 a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2026-05-16 under approval 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. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K260840.
When was BluEX Cervical Expandable Cage System approved by the FDA?
BluEX Cervical Expandable Cage System received FDA 510(k) clearance on 2026-05-16, under approval number K260840.
What company makes BluEX Cervical Expandable Cage System?
BluEX Cervical Expandable Cage System is manufactured by L&K BIOMED Co., Ltd..
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 Devices by L&K BIOMED Co., Ltd.
Related Devices (Code: ODP)
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.