Fx Shoulder USA, Inc. FDA Approvals

0 new drug approvals and 6 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
Full Wedge Lateralized and Augmented Baseplates510(k)May 15, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 15, 2024
FX V135(TM) Shoulder Prosthesis510(k)Jun 5, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 5, 2023
Humeris® 135 Shoulder System510(k)Nov 7, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 7, 2022
FX V135 Shoulder Prosthesis510(k)Jun 7, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 7, 2022
Lateralized and Augmented Baseplates510(k)Aug 25, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 25, 2021
Easytech® Anatomical Shoulder System510(k)Feb 16, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 16, 2021