Clearance Summary
BluEX Cervical Expandable Cage System received FDA 510(k) clearance under submission number K262489, sponsored by L&K BIOMED Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-08-18.
- Submission: K262489
- Applicant / Sponsor: L&K BIOMED Co., Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2026-08-18
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.