Degen Medical FDA Approvals

0 new drug approvals and 10 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
DeGen Medical Patient Specific Implant (PSI) System510(k)Dec 8, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 8, 2025
DeGen Medical Latitude-C AM Cervical Interbody Fusion System510(k)Oct 10, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 10, 2025
DeGen Medical Patient Specific Implant (PSI) System510(k)Apr 4, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 4, 2025
DeGen Medical Patient Specific Implant (PSI) System510(k)Oct 29, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 29, 2024
Solar Lumbar Interbody Fusion System510(k)Jun 16, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 16, 2023
DeGen Impulse AM System510(k)Mar 17, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 17, 2023
DeGen Navigated Instrumentation510(k)Feb 9, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 9, 2022
Cyclops Anterior Cervical Plate System510(k)Jan 7, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jan 7, 2022
Impulse AM Interbody Fusion System510(k)Aug 30, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 30, 2021
DeGen Navigated Instrumentation510(k)Apr 2, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 2, 2021