510(k) K253130

Dione PEEK Screw System by ZheJiang Decans Medical Devices Co., Ltd. — Product Code MBI

K253130 is an FDA 510(k) premarket notification submitted by ZheJiang Decans Medical Devices Co., Ltd. for the device "Dione PEEK Screw System". The FDA issued a decision of Substantially Equivalent on May 27, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. ZheJiang Decans Medical Devices Co., Ltd. has at least 10 other 510(k) clearances on record.