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FDA 510(k) Applications Submitted by Auxein Medical Private Limited
FDA 510(k) Number
Submission Date
Device Name
Applicant
K211324
04/30/2021
2.4mm Distal Radius System
Auxein Medical Private Limited
K210792
03/15/2021
Auxein Nailing System
Auxein Medical Private Limited
K192003
07/26/2019
Auxein Nailing System
Auxein Medical Private Limited
K213014
09/20/2021
Varixis Elbow System
Auxein Medical Private Limited
K213018
09/20/2021
Auxilock GFS Mini, GFS II Large, and GFS Ultimate
Auxein Medical Private Limited
K213059
09/22/2021
Tibia and Fibula System
Auxein Medical Private Limited
K213104
09/24/2021
Auxilock Titanium Screw-In Suture Anchor
Auxein Medical Private Limited
K213108
09/24/2021
Humerus & Ulna System
Auxein Medical Private Limited
K213109
09/24/2021
Auxilock Draw Tight Suture-Based Anchor
Auxein Medical Private Limited
K213110
09/24/2021
AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor
Auxein Medical Private Limited
K203029
10/02/2020
Auxilock Titanium Interference Screw
Auxein Medical Private Limited
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