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Depuy, A Johnson & Johnson Co.

USA · Warsaw

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

34listed device types

Class I 5Class II 27Class III 2

plus 71 registration records and 72 510(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

0active device licences

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 States71 registration records, 72 510(k), 4 PMA, 38 excluded

Brazil0 confirmed, 15 excluded

Saudi Arabia0 confirmed, 7 excluded

Canada0 confirmed, 9 excluded

Manufacturer names merged into this page: JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.

Same-named companies — This database also contains companies with near-identical names: JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

72004

42005

62006

52007

52008

32009

62010

62011

82012

132013

62014

32015

FDA listed device types

showing 8 of 34

Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Screw, Fixation, Bone 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1Cement Obturator 1Appliance, Fixation, Spinal Interlaminal 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K150209	Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc	2015-10-06
US	K143660	Milagro / Milagro Advance Interference Screw	2015-05-21
US	K141385	DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)	2015-03-27

Depuy, A Johnson & Johnson Co.

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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