FDA 510(k) Applications Submitted by RAHUL LUTHRA

FDA 510(k) Number Submission Date Device Name Applicant
K210792 03/15/2021 Auxein Nailing System Auxein Medical Private Limited
K141680 06/23/2014 AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws AUXEIN MEDICAL
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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