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TORNIER, INC.

USA · Bloomington

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 9 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

68listed device types

Class I 41Class II 27Class III 0

plus 208 registration records and 96 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

15registered devices

Class I 13Class II 2

18 including historic records

SASaudi ArabiaSFDA

37registered imported devices

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

CACanadaMDALL

2active device licences

Class II 1Class III 1

41 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

5device registrations

CLASS B 1CLASS C 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

162active ARTG entries

Class I 52Class III 43IIa 28IIb 39

HKHong KongMDACS

10valid listings

Class II 4Class III 6

ILIsraelAMAR

8registrations

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 States208 registration records, 96 510(k), 0 PMA, 5 excluded

Brazil15 confirmed, 3 excluded

Saudi Arabia37 confirmed, 1 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: TORNIER Inc. · TORNIER, INC. · TORNIER, SAS · TORNIER INC. · TORNIER INC · TORNIER

FDA 510(k) clearances by year

92006

22007

42008

62009

42010

92011

92012

42013

22014

42015

22016

12017

32018

32019

22020

22021

22022

12023

12025

22026

FDA listed device types

showing 8 of 68

Template 1Hook, Bone 1Forceps 1Rasp 1Probe 1Pusher, Socket 1Clamp 1Impactor 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260721	Tornier Perform Advanced Glenoid	2026-07-22
US	K252788	Tornier Perform Reversed Monopost Glenoid (Perform Mono)	2026-01-08
US	K251686	Tornier Humeral Reconstruction System Max (Tornier HRS Max)	2025-10-30
BR	80005430774	Instrumental Perform Humeral - Prova de Insertos Retentivos Simétricos	Class I
BR	80005430775	INSTRUMENTAL PERFORM HUMERAL - PROVA DE HASTES	Class I
BR	80005430776	INSTRUMENTAL PERFORM HUMERAL - PROVA DE INSERTOS ESPECIAIS	Class I
SA	ME0000006419SFDAA00050	Cut Ring	—
SA	ME0000006419SFDAA00057	Aequalis Humeral Nail	—
CA	71527	OSTEOCURE RESORBABLE BEAD KITS	Class III
CA	81388	3.5 MM DRILL BIT	Class II

TORNIER, INC.

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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