ZSFab, 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
ZSAlign Cervical Interbody System510(k)Jul 31, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 31, 2026
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System510(k)Apr 24, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 24, 2026
ZSFab Lumbar Interbody System510(k)Nov 25, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Nov 25, 2025
ZSFab Cervical Interbody System510(k)Aug 18, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 18, 2023
ZSFab Lumbar Interbody System510(k)Oct 14, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 14, 2022
ZSFab Cervical Interbody System510(k)Jan 7, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 7, 2021