Blue Ortho FDA Approvals

0 new drug approvals and 4 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
ExactechGPS® System510(k)Jan 26, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 26, 2024
ExactechGPS® Total Ankle Application510(k)Nov 16, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 16, 2023
ExactechGPS® System510(k)May 2, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	May 2, 2022
ExactechGPS Total Shoulder Application, Equinoxe Planning Software510(k)Jan 6, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 6, 2022