meddevicedb.com FDA Device Reference

BluEX Cervical Expandable Cage System

K260840 Class II Traditional
Decision Date
2026-05-16
Sponsor / Applicant
L&K BIOMED Co., Ltd.

Technical Specification

510(k) Submission ID K260840
Product Code ODP
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3080
Decision Date 2026-05-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

BluEX Cervical Expandable Cage System received FDA 510(k) clearance under submission number K260840, sponsored by L&K BIOMED Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-05-16.

Classification & Regulation

This clearance is catalogued under FDA product code ODP and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.