Innovasis, Inc. FDA Approvals

0 new drug approvals and 8 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
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)510(k)Jul 23, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 23, 2025
Innovasis Navigation Instruments510(k)Mar 24, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 24, 2025
Vector Pedicle Screw System510(k)May 20, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 20, 2024
HAtetracell-C Titanium Cervical IBF System510(k)Oct 17, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 17, 2023
Excella Navigation Instruments510(k)May 2, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	May 2, 2023
Matrix HA Fusion Porous Cervical IBF System510(k)Dec 12, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Dec 12, 2022
HAcancellous PEEK-C Porous HA PEEK Cervical IBF System510(k)Aug 26, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 26, 2022
AxTiHA Stand-Alone ALIF System510(k)Oct 15, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Oct 15, 2021