Genesys Spine 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
SIros-X System510(k)Oct 22, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 22, 2025
Genesys Spine AIS-C II Cervical Interbody Fusion System510(k)Feb 7, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 7, 2025
Genesys Spine Sacroiliac Joint Fusion System with Navigation510(k)Mar 29, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 29, 2024
Genesys Spine 3DP AIS-C II Cervical Interbody System510(k)Dec 13, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Dec 13, 2023
Genesys Spine 3DP Lumbar Interbody System510(k)Mar 9, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 9, 2022