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Medacta International, SA

Switzerland · Castel San Pietro

✓ 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

109listed device types

Class I 48Class II 61Class III 0

plus 618 registration records and 209 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

35registered devices

Class I 15Class II 20

64 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

54 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 States618 registration records, 209 510(k), 0 PMA

Brazil35 confirmed, 0 excluded

Manufacturer names merged into this page: MEDACTA INTERNATIONAL SA · MEDACTA INTERNATIONAL S.A.

FDA 510(k) clearances by year

52008

52009

72010

82011

102012

92013

82014

32015

62016

202017

102018

132019

262020

262021

132022

142023

42024

152025

72026

FDA listed device types

showing 8 of 109

Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Cerclage, Fixation 1Drape, Surgical, Exempt 1Screw, Fixation, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261016	MSS - Humeral reverse liners extension	2026-06-10
US	K254202	MectaLIF 3D Metal Anterior	2026-05-05
US	K253940	M.U.S.T. Pedicle Screw System - Extension	2026-04-28
BR	80102512019	INSTRUMENTAL DE COLUNA NÃO ESTÉRIL - REUTILIZÁVEL	Class I
BR	80102511770	INSTRUMENTAL DE JOELHO NÃO ESTÉRIL	Class II
BR	80102512422	INSTRUMENTAIS MYSPINE	Class II

Medacta International, 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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