K260840
- 510(k) number
- K260840
- Device name
- BluEX Cervical Expandable Cage System
- Applicant
- L&K BIOMED Co., Ltd. KR
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2026-05-16
- Date received
- 2026-03-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K260840.pdf
Official FDA record: K260840
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.