510(k) K213018

Auxilock GFS Mini, GFS II Large, and GFS Ultimate by Auxein Medical Private Limited — Product Code MBI

K213018 is an FDA 510(k) premarket notification submitted by Auxein Medical Private Limited for the device "Auxilock GFS Mini, GFS II Large, and GFS Ultimate". The FDA issued a decision of Substantially Equivalent on November 18, 2022. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Auxein Medical Private Limited has at least 10 other 510(k) clearances on record.