Auxein Medical Private Limited FDA Approvals

0 new drug approvals and 11 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Auxein's DHS/DCS Plate System510(k)Nov 30, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 30, 2023
Tibia and Fibula System510(k)Jan 27, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 27, 2023
AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor510(k)Dec 16, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 16, 2022
Auxilock GFS Mini, GFS II Large, and GFS Ultimate510(k)Nov 18, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 18, 2022
Humerus & Ulna System510(k)Nov 4, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 4, 2022
Varixis Elbow System510(k)Oct 3, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 3, 2022
Auxilock Draw Tight Suture-Based Anchor510(k)Aug 22, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 22, 2022
Auxilock Titanium Screw-In Suture Anchor510(k)Jul 29, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 29, 2022
2.4mm Distal Radius System510(k)Mar 14, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 14, 2022
Auxein Nailing System510(k)Aug 25, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 25, 2021
Auxilock Titanium Interference Screw510(k)Aug 20, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 20, 2021