K252542
- 510(k) number
- K252542
- Device name
- LEO Spinal System
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd. CN
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-04-29
- Date received
- 2025-08-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252542.pdf
Official FDA record: K252542
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.