University of Utah, Department of Orthopaedics 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
CoAptix S System510(k)Apr 10, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 10, 2026
Bone Bolt System510(k)Jun 26, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 26, 2023