510(k) K221364

Mitek TIGHT-N Anchor by Medos International SARL — Product Code MBI

K221364 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "Mitek TIGHT-N Anchor". The FDA issued a decision of Substantially Equivalent on July 11, 2022. 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 at least 10 other 510(k) clearances on record.