510(k) K232886

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button by Healthium Medtech Limited — Product Code MBI

K232886 is an FDA 510(k) premarket notification submitted by Healthium Medtech Limited for the device "INFILOOP® Fixed Loop UHMWPE Suture Titanium Button". The FDA issued a decision of Substantially Equivalent on November 8, 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.