510(k) K192003

Auxein Nailing System by Auxein Medical Private Limited — Product Code JDS

K192003 is an FDA 510(k) premarket notification submitted by Auxein Medical Private Limited for the device "Auxein Nailing System". The FDA issued a decision of Substantially Equivalent on June 10, 2020. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Auxein Medical Private Limited has at least 10 other 510(k) clearances on record.