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Silony Medical International AG

Germany · Leinfelden Echterdingen Baden-Wurttemberg

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

21listed device types

Class I 11Class II 10Class III 0

plus 73 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 8

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

5 including historic records

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 States73 registration records, 13 510(k), 0 PMA, 1 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: SILONY MEDICAL GMBH · Silony Medical International AG

FDA 510(k) clearances by year

22017

32018

22019

12020

12021

12022

12023

22026

FDA listed device types

showing 8 of 21

Posterior Cervical Screw System 1Intervertebral Fusion Device With Bone Graft, Thoracic 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1Intervertebral Fusion Device With Integrated Fixation, Lumbar 1Orthopedic Stereotaxic Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253921	VERTICALE® Navigation Instruments	2026-06-26
US	K254148	VERTICALE GPS Instruments	2026-02-19
US	K223806	VERTICALE® Triangular Fixation System	2023-07-06
BR	82151260010	Instrumentais Cirúrgicos Testes Titânio Cages Roccia Silony	Class I
BR	82151260011	Instrumentais Cirúrgicos Aço Cages Roccia Silony	Class I
BR	82151260012	Instrumentais Cirúrgicos AÇO VERTICALE TLS	Class I

Silony Medical International 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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