510(k) K223889

Stativ® Knotted UHMWPE Suture Anchor by Healthium Medtech Limited — Product Code MBI

K223889 is an FDA 510(k) premarket notification submitted by Healthium Medtech Limited for the device "Stativ® Knotted UHMWPE Suture Anchor". The FDA issued a decision of Substantially Equivalent on March 22, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Healthium Medtech Limited has at least 4 other 510(k) clearances on record.