510(k) K210792

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

K210792 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 August 25, 2021. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Auxein Medical Private Limited has at least 10 other 510(k) clearances on record.