510(k) K243425

Guided DAS Surgical Kit by Talladium España, SL — Product Code KCT

K243425 is an FDA 510(k) premarket notification submitted by Talladium España, SL for the device "Guided DAS Surgical Kit". The FDA issued a decision of Substantially Equivalent on July 22, 2025. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Talladium España, SL has at least 6 other 510(k) clearances on record.