510(k) K203794

HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture by Medos International SARL — Product Code MBI

K203794 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture". The FDA issued a decision of Substantially Equivalent on Feb 1, 2021. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Medos International SARL has 95 other 510(k) clearances on record.