510(k) K243408

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

K243408 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 November 27, 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.