Home›USA›DEPUY SPINE, INC.

DEPUY SPINE, INC.

USA · Le Locle

✓ Record-verifiedregistrations found in 9 markets

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

108listed device types

Class I 64Class II 42Class III 1unclassified 1

plus 326 registration records and 78 510(k), 18 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 5Class II 3

17 including historic records

SASaudi ArabiaSFDA

166registered imported devices

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

CACanadaMDALL

16active device licences

Class II 4Class III 12

39 including historic records

TWTaiwanTFDA

4valid device licences

Class I 3Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

103active ARTG entries

Class I 74IIa 14IIb 13Class Im (measuring) 2

HKHong KongMDACS

5valid listings

Class II 3Class III 2

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 2Class 3 1

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 States326 registration records, 78 510(k), 18 PMA, 41 excluded

Brazil8 confirmed, 13 excluded

Saudi Arabia166 confirmed, 6 excluded

Canada16 confirmed, 7 excluded

Manufacturer names merged into this page: DEPUY SPINE, INC. · DEPUY SPINE SARL · DEPUY SPINE · DEPUY SPINE SARL. · DePuy Spine

FDA 510(k) clearances by year

92004

82005

72006

102007

152008

72009

102010

32011

22012

12013

22014

12018

12019

12020

12022

FDA listed device types

showing 8 of 108

Motor, Surgical Instrument, Ac-Powered 1Template 1Elevator 1Forceps 1Probe 1Chisel, Surgical, Manual 1Scissors, Orthopedic, Surgical 1Clamp 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222276	CONDUIT Cages; FIBERGRAFT BG Putty	2022-10-15
US	K201831	CONFIDENCE Spinal Cement System	2020-08-31
US	K183054	SYNMESH System	2019-05-23
BR	80145901859	Instrumentais Expedium Osteotomy	Class I
BR	80145901478	AGULHAS CONFIDENCE	Class II
BR	80145909042	KIT INSTRUMENTAL TLIF	Class I
SA	ME0000000723SFDAA00237	EXPEDIUM™ SPINE SYSTEM EXTENDED TAB SCREW CADDY	—
SA	ME0000000723SFDAA00239	EXPEDIUM™ SPINE SYSTEM TANDEM CONNECTOR TRAY	—
CA	74144	SUMMIT OCT SPINAL SYSTEM HOOKS	Class III
CA	1671	UNIVERSITY PLATE ANTERIOR SYSTEM	Class III
CA	1673	M-2 ANTERIOR PLATE SYSTEM	Class III

DEPUY SPINE, INC.

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