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Fort Wayne Metals

USA · Fort Wayne IN · www.fwmetals.com

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

0UDI-DI device records

USUnited StatesFDA openFDA

16listed device types

Class I 6Class II 10Class III 0

plus 18 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

8registered devices

Class II 8

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

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 States18 registration records, 0 510(k), 0 PMA, 2 excluded

Brazil8 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: FORT WAYNE METALS RESEARCH PRODUCTS, LLC · FORT WAYNE METALS RESEARCH PRODUCTS CORP · Fort Wayne Metals

Business registration

Legal name: WAYNE METALS, LLC
LEI: 254900H467J1WJZOS364
Registration status: Active
Legal form: Limited Liability Company (Limited Liability Company)
Incorporated: 2001-02-09
Registered address: C/O Jerome F. Henry, Jr., Fort Wayne, 46802
Registration authority: Business Services Division (Secretary of State), no. 2001021300099
Registry record updated: 2024-10-13

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

showing 8 of 16

Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Pin, Fixation, Smooth 1Orthosis, Spinal Pedicle Fixation 1Orthosis, Spondylolisthesis Spinal Fixation 1Cerclage, Fixation 1Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile 1Fastener, Fixation, Nondegradable, Soft Tissue 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80398280014	Fio Ortodôntico cobre-nitinol Eurodonto	Class II
BR	80398280016	Fio Ortodôntico BIII Eurodonto	Class II
BR	80398280011	Fio Ortodôntico de Aço Inoxidável	Class II

Fort Wayne Metals

Registrations by market

How these numbers were verified

Company information

Business registration

FDA listed device types

Registration details (sample)

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