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Home›USA›TREACE MEDICAL CONCEPTS, INC.

TREACE MEDICAL CONCEPTS, INC.

USA · Ponte Vedra
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
25listed device types
Class I 21Class II 4Class III 0
plus 40 registration records and 100 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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 States40 registration records, 100 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: TREACE MEDICAL CONCEPTS, INC.
Same-named companies — This database also contains companies with near-identical names: Treace Medical, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Ponte Vedra

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

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

231982
191983
91984
21985
101986
141987
21988
11989
12015
12016
12017
12018
32019
12020
12021
32022
22023
42024
12025
12026

FDA listed device types

showing 8 of 25
Template 1Rasp 1Chisel, Surgical, Manual 1Guide, Surgical, Instrument 1Screwdriver 1Gauge, Depth 1Broach 1Tamp 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260361Treace Medical Concepts (TMC) Screw Fixation System2026-03-06
USK251135Treace Medical Concepts (TMC) Implant Fixation System2025-08-21
USK243658TMC Compression Implant System2024-12-26

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