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STRYKER TRAUMA S.A.

Switzerland · Geneva

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Israel — 7 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

16listed device types

Class I 7Class II 9Class III 0

plus 63 registration records and 32 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 5Class II 3

9 including historic records

SASaudi ArabiaSFDA

11registered imported devices

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

CACanadaMDALL

9active device licences

Class II 2Class III 7

16 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States63 registration records, 32 510(k), 0 PMA, 10 excluded

Brazil8 confirmed, 5 excluded

Saudi Arabia11 confirmed, 1 excluded

Canada9 confirmed, 4 excluded

Manufacturer names merged into this page: STRYKER TRAUMA GMBH · STRYKER TRAUMA S.A. · STRYKER TRAUMA GMBH (SCHONKIRCHEN) · Stryker Trauma GmbH

FDA 510(k) clearances by year

112013

112014

32015

22017

22018

12019

22020

FDA listed device types

showing 8 of 16

Rod, Fixation, Intramedullary And Accessories 1Fastener, Fixation, Biodegradable, Soft Tissue 1Staple, Fixation, Bone 1Pin, Fixation, Smooth 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Plate, Fixation, Bone 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Screw, Fixation, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200869	Gamma3 System	2020-07-22
US	K193308	T2 Alpha Tibia Nailing System, IMN Screws System	2020-02-23
US	K191271	T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System	2019-06-11
BR	80005430392	Instrumental Stryker não Articulado não Cortante Orthopaedics	Class I
BR	80005430388	INSTRUMENTAL NÃO ARTICULADO CORTANTE PARA OSTEOSSÍNTESE	Class I
BR	80005430434	Instrumental Não Articulado e Não cortante de Peek Stryker	Class I
SA	ME0000005428SFDAA00045	Implant Extraction Set System Instrument Set	—
SA	ME0000005428SFDAA00046	Bixcut System Modular Reamer Kit	—
CA	15273	EX-FI-RE EXTERNAL FIXATION SYSTEM	Class III
CA	10379	BWM FRACTURE SYSTEM	Class III
CA	10385	INTRAMEDULLARY NAIL	Class III

STRYKER TRAUMA S.A.

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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