Home›USA›INNOVASIS, INC.

INNOVASIS, INC.

USA · Salt Lake City

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

20listed device types

Class I 4Class II 16Class III 0

plus 37 registration records and 35 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States37 registration records, 35 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: INNOVASIS, INC. · INNOVASIS, INC

FDA 510(k) clearances by year

22004

22006

12007

12010

12012

42014

22015

12016

12017

32018

52019

22020

12021

22022

22023

12024

42025

FDA listed device types

showing 8 of 20

Posterior Cervical Screw System 1Light, Surgical, Fiberoptic 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Orthosis, Spondylolisthesis Spinal Fixation 1Appliance, Fixation, Spinal Interlaminal 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250076	Endeavor Stand-Alone Cervical IBF System	2025-09-25
US	K251073	Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)	2025-07-23
US	K250182	Innovasis Navigation Instruments	2025-03-24
BR	80530040003	INSTRUMENTAL PARA SISTEMA DE COLUNA VERTEBRAL ETHOS	Class I
BR	80530040007	INSTRUMENTAL PARA ESPAÇADORES INTERVERTEBRAIS ETHOS	Class I
BR	80530040008	INSTRUMENTAL PARA ESPAÇADORES INTERVERTEBRAIS L-SPACER ETHOS	Class I

INNOVASIS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies