Aju Pharm Co., Ltd. FDA Approvals

0 new drug approvals and 5 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
Fixone Meniscal Repair510(k)Aug 2, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 2, 2024
Fixone Biocomposite Anchor510(k)Jun 9, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jun 9, 2023
Fixone All Suture Anchor510(k)Mar 23, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 23, 2023
Fixone hybrid knotless anchor510(k)Dec 25, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 25, 2021
Fixone Biocomposite Interference Screw510(k)Jan 5, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 5, 2021