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Auxein Medical Private Limited

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K221787Auxein's DHS/DCS Plate SystemNovember 30, 2023
K213059Tibia and Fibula SystemJanuary 27, 2023
K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorDecember 16, 2022
K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateNovember 18, 2022
K213108Humerus & Ulna SystemNovember 4, 2022
K213014Varixis Elbow SystemOctober 3, 2022
K213109Auxilock Draw Tight Suture-Based AnchorAugust 22, 2022
K213104Auxilock Titanium Screw-In Suture AnchorJuly 29, 2022
K2113242.4mm Distal Radius SystemMarch 14, 2022
K210792Auxein Nailing SystemAugust 25, 2021
K203029Auxilock Titanium Interference ScrewAugust 20, 2021
K192003Auxein Nailing SystemJune 10, 2020