Spineology, Inc. FDA Approvals

0 new drug approvals and 6 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
OptiMesh Multiplanar Expandable Interbody Fusion System510(k)Dec 15, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 15, 2025
Spineology Navigation Instruments510(k)Dec 4, 2025Neurology	Neurology	510(k)Substantially Equivalent (Special)	Dec 4, 2025
OptiMesh Multiplanar Expandable Interbody Fusion System510(k)Nov 1, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 1, 2023
OptiMesh Multiplanar Expandable Interbody Fusion System510(k)Oct 18, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Oct 18, 2023
Spineology Navigation Instruments510(k)Aug 5, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 5, 2022
Duo Expandable Interbody Fusion System510(k)Feb 19, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Feb 19, 2021