Nexus Spine, LLC FDA Approvals

0 new drug approvals and 11 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
Stable-L Lumbar Interbody System510(k)Apr 30, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 30, 2025
Stable-C Interbody System510(k)Jul 17, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 17, 2024
Tranquil-L Interbody System510(k)Mar 20, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 20, 2024
Tranquil-C Interbody System510(k)Mar 12, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 12, 2024
PressON Spinal Fixation System510(k)Oct 26, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Oct 26, 2023
Stable-L Standalone Lumbar Interbody System510(k)Oct 12, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 12, 2023
Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System510(k)Sep 18, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 18, 2023
Stable-C Interbody System510(k)Aug 21, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 21, 2023
PressON Spinal Fixation System510(k)May 2, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 2, 2023
PreView-III Anterior Cervical Plate System510(k)Feb 2, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 2, 2023
Stable-L Standalone Lumbar Interbody System510(k)Mar 18, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 18, 2022