SPINEART SA

Switzerland · Plan-Les-Ouates Geneve

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Israel, Russia — 7 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

48listed device types

Class I 33Class II 14Class III 1

plus 102 registration records and 57 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

20registered devices

Class I 17Class II 3

36 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

24device registrations

CLASS B 14CLASS C 10

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

18active ARTG entries

Class I 1Class III 1IIa 2IIb 14

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

9active registrations

Class 1 1Class 3 8

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 States102 registration records, 57 510(k), 0 PMA

Brazil20 confirmed, 0 excluded

Manufacturer names merged into this page: SPINEART SA · SPINEART

FDA 510(k) clearances by year

12008

32009

32010

22011

12012

12013

82014

22015

52016

22017

42018

42019

52020

22021

12022

32023

42024

22025

42026

FDA listed device types

showing 8 of 48

Template 1Rasp 1Probe 1Dispenser, Cement 1Impactor 1Razor, Surgical 1Guide, Surgical, Instrument 1Screwdriver 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262639	BAGUERA® C Cervical Disc Surgical Instruments	2026-08-14
US	K261205	SPINEART Navigation Instrument System	2026-07-29
US	K253966	PERLA® TL Posterior Thoraco-lumbar Fixation System	2026-05-01
BR	81000030001	Instrumental para cages lombares Juliet	Class I
BR	81000030042	Instrumental para Cage cervical Stand alone Scarlet AC T	Class I
BR	80239410010	INSTRUMENTAL PARA IMPLANTE DE DISCO CERVICAL BAGUERAc	Class I

SPINEART SA

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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