Fusion Innovations, LLC FDA Approvals

0 new drug approvals and 2 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
SternaFuse Ti Fixation System510(k)Nov 19, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 19, 2025
SternaFuse Fixation System510(k)Jan 26, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 26, 2022