510(k) K250304

TITANEX Screw Systems by Vilex, LLC — Product Code HWC

K250304 is an FDA 510(k) premarket notification submitted by Vilex, LLC for the device "TITANEX Screw Systems". The FDA issued a decision of Substantially Equivalent on March 5, 2025. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Vilex, LLC has at least 10 other 510(k) clearances on record.