510(k) K240035

TACTIX Vector Syndesmosis System by Vilex, LLC — Product Code HTN

K240035 is an FDA 510(k) premarket notification submitted by Vilex, LLC for the device "TACTIX Vector Syndesmosis System". The FDA issued a decision of Substantially Equivalent on August 1, 2024. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Vilex, LLC has at least 10 other 510(k) clearances on record.