Medical Device Manufacturer · IN , Sonipat

Auxein Medical Private Limited - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2020
12
Total
12
Cleared
0
Denied

Auxein Medical Private Limited has 12 FDA 510(k) cleared orthopedic devices. Based in Sonipat, IN.

Latest FDA clearance: Nov 2023. Active since 2020.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

12 devices
1–12 of 12
Auxein's DHS/DCS Plate System
K221787 · KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · Orthopedic
Nov 2023 527d
Tibia and Fibula System
K213059 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2023 492d
AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor
K213110 · MBI Fastener, Fixation, Nondegradable, Soft Tissue · Orthopedic
Dec 2022 448d
Auxilock GFS Mini, GFS II Large, and GFS Ultimate
K213018 · MBI Fastener, Fixation, Nondegradable, Soft Tissue · Orthopedic
Nov 2022 424d
Humerus & Ulna System
K213108 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2022 406d
Varixis Elbow System
K213014 · HRS Plate, Fixation, Bone · Orthopedic
Oct 2022 378d
Auxilock Draw Tight Suture-Based Anchor
K213109 · MBI Fastener, Fixation, Nondegradable, Soft Tissue · Orthopedic
Aug 2022 332d
Auxilock Titanium Screw-In Suture Anchor
K213104 · MBI Fastener, Fixation, Nondegradable, Soft Tissue · Orthopedic
Jul 2022 308d
2.4mm Distal Radius System
K211324 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2022 318d
Auxein Nailing System
K210792 · HWC Screw, Fixation, Bone · Orthopedic
Aug 2021 163d
Auxilock Titanium Interference Screw
K203029 · HWC Screw, Fixation, Bone · Orthopedic
Aug 2021 322d
Auxein Nailing System
K192003 · JDS Nail, Fixation, Bone · Orthopedic
Jun 2020 320d
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