510(k) K203029

Auxilock Titanium Interference Screw by Auxein Medical Private Limited — Product Code HWC

K203029 is an FDA 510(k) premarket notification submitted by Auxein Medical Private Limited for the device "Auxilock Titanium Interference Screw". The FDA issued a decision of Substantially Equivalent on August 20, 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.