Evolution Spine FDA Approvals

0 new drug approvals and 9 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
E3D-C Interbody System510(k)Jul 22, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jul 22, 2026
E3D-C Interbody System510(k)Feb 4, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Feb 4, 2026
Evolution Spine Navigation Instruments510(k)Aug 18, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 18, 2025
E3D-C Interbody System510(k)Aug 12, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 12, 2024
E3D-A Interbody System510(k)May 15, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 15, 2024
E3D-A Interbody System510(k)Jan 30, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 30, 2024
EVOLUTION SPINE Interbody System510(k)Feb 7, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 7, 2023
EMERGE Anterior Cervical Plate System510(k)Mar 18, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 18, 2022
EMERGE Anterior Cervical Plate System510(k)Sep 30, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Abbreviated)	Sep 30, 2021