Home›France›Tornier S.A.S.

Tornier S.A.S.

France · Montbonnot-Saint-Martin

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Hong Kong, Israel — 8 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

45listed device types

Class I 30Class II 15Class III 0

plus 94 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

20registered devices

Class I 15Class II 5

26 including historic records

SASaudi ArabiaSFDA

44registered imported devices

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

CACanadaMDALL

10active device licences

Class II 1Class III 9

43 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

1registrations

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 States94 registration records, 20 510(k), 0 PMA, 7 excluded

Brazil20 confirmed, 4 excluded

Saudi Arabia44 confirmed, 1 excluded

Canada10 confirmed, 1 excluded

Manufacturer names merged into this page: Tornier S.A.S. · TORNIER S.A.S · TORNIER S.A.S. · Tornier S.A.S

FDA 510(k) clearances by year

52013

32014

22015

42016

12017

12019

12021

12022

12023

12024

FDA listed device types

showing 8 of 45

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented 1Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained 1Prosthesis, Elbow, Hemi-, Radial, Polymer 1Shoulder Arthroplasty Implantation System 1Prosthesis, Elbow, Semi-Constrained, Cemented 1Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis 1Prosthesis, Elbow, Constrained, Cemented 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232265	BLUEPRINT Patient Specific Instrumentation	2024-02-21
US	K222510	Blueprint Mixed Reality system	2023-01-20
US	DEN220012	Tornier Pyrocarbon Humeral Head	2022-12-16
BR	80005430783	Instrumental Tornier PerForm Reversed - Lower	Class I
BR	80005430786	Instrumental Tornier PerForm Reversed - Upper	Class I
BR	80005439052	TORNIER FLEX Shoulder System Instruments 2	Class I
SA	ME0000006420SFDAA00048	Aequalis Ascend Flex	—
SA	ME0000006420SFDAA00049	Aequalis Ascend flex	—
CA	74248	AEQUALIS RESURFACING HEAD	Class III
CA	74487	SALTO TALARIS ANATOMIC ANKLE SYSTEM	Class III
CA	92553	MAXLOCK EXTREME SYSTEM	Class III

Tornier S.A.S.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies