BluEX Cervical Expandable Cage System— 510(k) K260840
Substantially EquivalentL&K BIOMED Co., Ltd.
FDA 510(k) clearance K260840 for BluEX Cervical Expandable Cage System, Substantially Equivalent on 2026-05-16. Applicant: L&K BIOMED Co., Ltd.. Device class: 2.
Summary
L&K BIOMED's BluEX Cervical Expandable Cage System is filed under ODP, cervical intervertebral fusion devices with bone graft.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
L&K BIOMED filed from Yongin-Si, South Korea. The decision came 61 calendar days after receipt (March 16 to May 16, 2026).
Clearance details
- Applicant
- L&K BIOMED Co., Ltd.
- Product code
- Product code ODP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yongin-Si, KR
Recent devices under product code ODP
view allMore clearances from L&K BIOMED Co., Ltd.
view allAdverse events under product code ODP
product code ODP- Injury
- 310
- Total
- 310
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.