Orthosoft D/B/A Zimmer Cas FDA Approvals

0 new drug approvals and 7 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
ROSA Partial Knee System510(k)Nov 16, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 16, 2023
ROSA® Knee System510(k)Mar 29, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 29, 2023
ROSA® Knee System510(k)Oct 4, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 4, 2022
iASSIST Knee System510(k)Jan 14, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 14, 2022
ROSA Hip System510(k)Aug 17, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 17, 2021
ONE Planner Hip510(k)Jul 7, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 7, 2021
ROSA Partial Knee System510(k)Apr 19, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 19, 2021