Surgalign Spine Technologies 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
HOLO Portal Surgical Guidance System510(k)Aug 31, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 31, 2023
Cortera Spinal Fixation System510(k)Aug 19, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 19, 2022
ARAI Surgical Navigation System510(k)Jan 14, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 14, 2022