LEO Spinal System
K-Number: K252542 · 2026-04-29
Decision Date2026-04-29
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
LEO Spinal System is a medical device manufactured by ZheJiang Decans Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2026-04-29 under approval number K252542. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LEO Spinal System?
LEO Spinal System is a medical device that received FDA 510(k) clearance on 2026-04-29. It is manufactured by ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K252542.
When was LEO Spinal System approved by the FDA?
LEO Spinal System received FDA 510(k) clearance on 2026-04-29, under approval number K252542.
What company makes LEO Spinal System?
LEO Spinal System is manufactured by ZheJiang Decans Medical Devices Co., Ltd..
What is the FDA product code for LEO Spinal System?
The FDA product code for LEO Spinal System is NKB.
Other Devices by ZheJiang Decans Medical Devices Co., Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.