Aurora Spine, Inc. FDA Approvals

0 new drug approvals and 5 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
SILO TFX MIS Sacroiliac Joint Fixation System510(k)Oct 3, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 3, 2022
ZIP MIS Interspinous Fusion System510(k)Jul 8, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 8, 2022
SOLO-L510(k)May 27, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 27, 2022
DEXA-C Cervical Interbody System510(k)Aug 2, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 2, 2021
APOLLO Anterior Cervical Plate (ACP) System510(k)Mar 23, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 23, 2021