LEO Spinal System— 510(k) K252542
Substantially EquivalentZheJiang Decans Medical Devices Co., Ltd.
FDA 510(k) clearance K252542 for LEO Spinal System, Substantially Equivalent on 2026-04-29. Applicant: ZheJiang Decans Medical Devices Co., Ltd.. Device class: 2.
Summary
ZheJiang Decans Medical Devices' LEO Spinal System is filed under product code NKB (Thoracolumbosacral Pedicle Screw System).
Class II, 21 CFR 888.3070. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
ZheJiang Decans filed from Jiaxing City, China. The record shows 260 calendar days from receipt to decision (August 12, 2025 to April 29, 2026).
Clearance details
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd.
- Product code
- Product code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jiaxing City, CN
Recent devices under product code NKB
view allMore clearances from ZheJiang Decans Medical Devices Co., Ltd.
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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.