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Zavation Medical Products, LLC FDA Approvals

0 new drug approvals and 15 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
Tiger 2 System510(k)Jul 24, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 24, 2026
Tiger 2 System510(k)Feb 3, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 3, 2025
Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System510(k)Apr 10, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 10, 2024
Zavation Connector System510(k)Aug 22, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 22, 2023
Zavation Navigation Instrument System510(k)Jul 12, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 12, 2023
Zavation ALIF System510(k)Jun 14, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 14, 2023
Uni-FuZe-C Bone Strip510(k)Jan 18, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 18, 2023
Zavation Spinal System510(k)Dec 5, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 5, 2022
Zavation VariSync Plate System and VariSync Spacer System510(k)Aug 12, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 12, 2022
Zavation eZspand Interbody System510(k)Jun 2, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 2, 2022
Ti3Z Lumbar Interbody System510(k)Apr 12, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 12, 2022
Z-LINKPC System510(k)Aug 11, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 11, 2021
Zavation Spinal System510(k)Jul 12, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 12, 2021
LABYRINTH510(k)Jun 24, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 24, 2021
Ti3Z Cervical Interbody System510(k)Jan 29, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 29, 2021

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