K242829
- 510(k) number
- K242829
- Device name
- BluEX Lumbar Expandable Cage System
- Applicant
- L&K BIOMED Co., Ltd. KR
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-10-23
- Date received
- 2024-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K242829.pdf
Official FDA record: K242829
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.