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SAFE ORTHOPAEDICS SAS

France · Fleurieux-Sur-L'Arbresle Rhone

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, Australia, Hong Kong — 4 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

10listed device types

Class I 3Class II 7Class III 0

plus 8 registration records and 13 510(k)

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

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IIa 1IIb 3

HKHong KongMDACS

1valid listings

Class III 1

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 States8 registration records, 13 510(k), 0 PMA, 34 excluded

Brazil0 confirmed, 9 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: SAFE ORTHOPAEDICS SAS

FDA 510(k) clearances by year

12011

22012

12013

22014

42015

12016

12017

12020

FDA listed device types

showing 8 of 10

Thoracolumbosacral Pedicle Screw System 1Arthroscope 1Orthosis, Spondylolisthesis Spinal Fixation 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Appliance, Fixation, Spinal Interlaminal 1Cement, Bone, Vertebroplasty 1Orthosis, Spinal Pedicle Fixation 1Instrument, Bending Or Contouring 1

Market	Identifier	Name	Class / date
US	K201648	Sterispine PS	2020-07-30
US	K170528	Sterispine PS	2017-03-09
US	K162531	STERISPINE CC	2016-12-29

SAFE ORTHOPAEDICS SAS

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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