BluEX Cervical Expandable Cage System— 510(k) K262489
Substantially EquivalentL&K BIOMED Co., Ltd.
FDA 510(k) clearance K262489 for BluEX Cervical Expandable Cage System, Substantially Equivalent on 2026-08-18. Applicant: L&K BIOMED Co., Ltd.. Device class: 2.
Summary
L&K BIOMED's BluEX Cervical Expandable Cage System is filed under product code ODP, cervical intervertebral fusion devices with bone graft. The record gives no model numbers.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).
L&K BIOMED filed from Yongin-Si, South Korea. The decision came 29 calendar days after receipt (July 20 to August 18, 2026), and it was substantially equivalent.
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
- Special
- 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.