510(k) clearance
BluEX Cervical Expandable Cage System
- 510(k) number
- K262489
- Applicant
- L&K BIOMED Co., Ltd.
- Decision date
- Aug 18, 2026
- Date received
- Jul 20, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- ODP
- Device type
- Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II
- Regulation
- 21 CFR 888.3080
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Yongin-Si, KR