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Medical Concepts, Inc.

USA · Derby

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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

28listed device types

Class I 24Class II 4Class III 0

plus 43 registration records and 102 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

1active device licences

Class II 1

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

28active ARTG entries

Class I 4IIa 11Class Is (sterile) 13

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 States43 registration records, 102 510(k), 0 PMA, 88 excluded

Brazil1 confirmed, 7 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada1 confirmed, 9 excluded

Manufacturer names merged into this page: TREACE MEDICAL CONCEPTS, INC. · MEDICAL CONCEPTS · MEDICAL CONCEPTS EUROPE B.V. · MEDICAL CONCEPTS LTD. · MEDICAL CONCEPTS DEVELOPMENT, INC.

Business registration

Legal name: TREACE MEDICAL CONCEPTS, INC.
CIK: 0001630627
Registration status: Active
Listing status: Listed (TMCI)

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

FDA 510(k) clearances by year

92001

72002

72003

22004

142005

12010

22011

22014

12015

22016

12017

12018

32019

12020

12021

32022

22023

42024

12025

12026

FDA listed device types

showing 8 of 28

Template 1Rasp 1Chisel, Surgical, Manual 1Guide, Surgical, Instrument 1Screwdriver 1Gauge, Depth 1Broach 1Tamp 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260361	Treace Medical Concepts (TMC) Screw Fixation System	2026-03-06
US	K251135	Treace Medical Concepts (TMC) Implant Fixation System	2025-08-21
US	K243658	TMC Compression Implant System	2024-12-26
BR	10150470192	CAMPO CIRURGICO MCD	Class II
CA	35833	I.V.S. TUNNELER	Class II

Medical Concepts, Inc.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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