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VILEX INCORPORATED

USA · Mcminnville

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Israel — 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

31listed device types

Class I 19Class II 12Class III 0

plus 50 registration records and 30 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class I 10Class II 1

15 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States50 registration records, 30 510(k), 0 PMA, 1 excluded

Brazil11 confirmed, 1 excluded

Manufacturer names merged into this page: Vilex LLC · Vilex Inc., · VILEX LLC · VILEX INCORPORATED

FDA 510(k) clearances by year

11998

21999

12002

32004

12005

12007

22011

12012

12014

22020

12021

32022

42023

52024

12025

12026

FDA listed device types

showing 8 of 31

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Ankle Arthroplasty Implantation System 1Rod, Fixation, Intramedullary And Accessories 1Staple, Fixation, Bone 1Prosthesis, Toe, Hemi-, Phalangeal 1Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer 1Plate, Fixation, Bone 1Software For Diagnosis/Treatment 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260900	DYNEX® External Fixation Systems	2026-04-17
US	K250304	TITANEX Screw Systems	2025-03-05
US	K240475	Hintermann Series H2 Total Ankle System	2024-12-02
BR	80638410045	FIXADOR EXTERNO VILEX II	Class I
BR	80638410047	ARCOS CIRCULARES E SEMI CIRCULARES PARA FIXADOR EXTERNO VILEX II	Class I
BR	80638410062	FIXADOR EXTERNO E Z-FIX RAIL VILEX	Class I

VILEX INCORPORATED

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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