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Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

USA · West Chester

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

189listed device types

Class I 98Class II 88Class III 1unclassified 2

plus 1,040 registration records and 509 510(k), 4 PMA

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

6active device licences

Class II 4Class III 2

32 including historic records

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 States1,040 registration records, 509 510(k), 4 PMA, 8 excluded

Brazil0 confirmed, 5 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada6 confirmed, 2 excluded

Manufacturer names merged into this page: DePuy Synthes Sales · Synthes (USA) Products LLC · DePuy Synthes West Palm Beach · SYNTHES USA LLC

FDA 510(k) clearances by year

142006

182007

252008

192009

162010

162011

102012

52013

122014

102015

42016

102017

102018

102019

92020

42021

32022

12023

52024

12026

FDA listed device types

showing 8 of 189

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	K254087	MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System	2026-06-11
US	K233696	DePuy Synthes Retrograde Femoral Nail Advanced System	2024-08-01
US	K233256	Robotic Integration Instruments	2024-06-17
CA	11506	NAILS - STAINLESS STEEL	Class III
CA	12040	SYNCAGE INTERVERTEBRAL FUSION SYSTEM	Class III
CA	64905	SMALL BATTERY DRIVE SET	Class II

Synthes (Usa) Products, LLC / Depuy Orthopaedics, 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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