Dev4 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
Eleganz IM Threaded Nail System (IM Threaded Nail System)510(k)Oct 10, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 10, 2025
Eleganz Fusion Screw System (Fusion Screw System)510(k)Jun 13, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 13, 2025