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Auxein Medical Private Limited

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories5
Latest FDA decision2023-11-30
TypeNumberDevice NameCodeDateActions
510(k) K221787 Auxein's DHS/DCS Plate SystemKTT2023-11-30 View
510(k) K213059 Tibia and Fibula SystemHRS2023-01-27 View
510(k) K213110 AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorMBI2022-12-16 View
510(k) K213018 Auxilock GFS Mini, GFS II Large, and GFS UltimateMBI2022-11-18 View
510(k) K213108 Humerus & Ulna SystemHRS2022-11-04 View
510(k) K213014 Varixis Elbow SystemHRS2022-10-03 View
510(k) K213109 Auxilock Draw Tight Suture-Based AnchorMBI2022-08-22 View
510(k) K213104 Auxilock Titanium Screw-In Suture AnchorMBI2022-07-29 View
510(k) K211324 2.4mm Distal Radius SystemHRS2022-03-14 View
510(k) K210792 Auxein Nailing SystemHWC2021-08-25 View
510(k) K203029 Auxilock Titanium Interference ScrewHWC2021-08-20 View
510(k) K192003 Auxein Nailing SystemJDS2020-06-10 View
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