Sc Medica FDA Approvals

0 new drug approvals and 3 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
FFX Facet Fixation System510(k)Dec 4, 2025	—	510(k)Substantially Equivalent (Traditional)	Dec 4, 2025
FFX Facet Fixation System510(k)Oct 16, 2025	—	510(k)Substantially Equivalent (Traditional)	Oct 16, 2025
SC Medica FFX510(k)May 9, 2024	—	510(k)Substantially Equivalent (Traditional)	May 9, 2024