Synthes, Inc.

Switzerland · Zuchwil

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

169listed device types

Class I 88Class II 77Class III 2unclassified 2

plus 1,012 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 2Class II 5

23 including historic records

SASaudi ArabiaSFDA

862registered imported devices

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

CACanadaMDALL

0active device licences

288 including historic records

TWTaiwanTFDA

91valid device licences

Class I 7Class II 83Class III 1

SGSingaporeHSA SMDR

218device registrations

CLASS B 28CLASS C 185CLASS D 4D WITH MEDICINAL PRODUCT 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

302active ARTG entries

Class I 135Class III 4IIa 84IIb 63Class Im (measuring) 11Class Is (sterile) 5

HKHong KongMDACS

133valid listings

Class II 33Class III 96Class IV 4

ILIsraelAMAR

87registrations

RURussiaRoszdravnadzor

17active registrations

Class 1 6Class 2a 5Class 2b 4Class 3 2

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 States1,012 registration records, 26 510(k), 0 PMA, 19 excluded

Brazil7 confirmed, 4 excluded

Saudi Arabia862 confirmed, 0 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: SYNTHES GMBH · Synthes GMBH · Synthes GmbH

FDA 510(k) clearances by year

11998

12000

22001

22002

12010

42011

42012

42013

22024

22025

32026

FDA listed device types

showing 8 of 169

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Cerclage, Fixation 1Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile 1Washer, Bolt Nut 1Appliance, Fixation, Spinal Interlaminal 1Driver, Wire, And Bone Drill, Manual 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254093	DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System	2026-03-10
US	K260069	DePuy Synthes VOLT Proximal Tibia 3.5 Plating System	2026-03-09
US	K254054	VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System	2026-03-02
BR	80145901681	Instrumental VA Intercarpal Fusion 2.4 mm	Class I
BR	80145901745	INSTRUMENTAL NÃO ARTICULADO NÃO CORTANTE - TRAUMA	Class I
BR	80145909108	Kit Instrumentais ANS	Class II
SA	ME0000005235SFDAA00024	Module LCP Compact Hand 2.4	—
SA	ME0000000735SFDAA01576	Vario Case f/Cervical Retractors and Distractors	—