ICOTEC AG.

Switzerland · Altstatten

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel — 6 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 1Class II 9Class III 0

plus 16 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

4device registrations

CLASS C 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

39active ARTG entries

Class I 32IIa 3IIb 3Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States16 registration records, 17 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: ICOTEC AG · ICOTEC AG.

FDA 510(k) clearances by year

12011

12016

12018

12019

52020

22023

42024

22025

FDA listed device types

showing 8 of 10

Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Bone Cement, Posterior Screw Augmentation 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1Spinal Vertebral Body Replacement Device 1Spinal Vertebral Body Replacement Device - Cervical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252327	CMORE® CT System; CMORE® CT System Navigated Instruments	2025-11-12
US	K242900	VADER® Pedicle System and VADER®one Pedicle System	2025-02-27
US	K233215	icotec Anterior Cervical Plate System	2024-05-17
BR	80120790088	Kit Instrumental para Sistema de Placa Cervical Anterior ICOTEC	Class II
BR	80120790085	Kit Instrumental para Cage Cervical ICOTEC	Class I
BR	80120790086	Kit Instrumental para Cage Lombar ICOTEC	Class I

ICOTEC AG.

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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