Auxein Medical Private Limited - FDA 510(k) Cleared Devices
Recent clearances: Auxein's DHS/DCS Plate System, Tibia and Fibula System, AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Auxein Medical Private Limited Orthopedic ✕
12 devices
Cleared
Nov 30, 2023
Auxein's DHS/DCS Plate System
Orthopedic
527d
Cleared
Jan 27, 2023
Tibia and Fibula System
Orthopedic
492d
Cleared
Dec 16, 2022
AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA...
Orthopedic
448d
Cleared
Nov 18, 2022
Auxilock GFS Mini, GFS II Large, and GFS Ultimate
Orthopedic
424d
Cleared
Nov 04, 2022
Humerus & Ulna System
Orthopedic
406d
Cleared
Oct 03, 2022
Varixis Elbow System
Orthopedic
378d
Cleared
Aug 22, 2022
Auxilock Draw Tight Suture-Based Anchor
Orthopedic
332d
Cleared
Jul 29, 2022
Auxilock Titanium Screw-In Suture Anchor
Orthopedic
308d
Cleared
Mar 14, 2022
2.4mm Distal Radius System
Orthopedic
318d
Cleared
Aug 25, 2021
Auxein Nailing System
Orthopedic
163d
Cleared
Aug 20, 2021
Auxilock Titanium Interference Screw
Orthopedic
322d
Cleared
Jun 10, 2020
Auxein Nailing System
Orthopedic
320d