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NEOORTHO PRODUTOS ORTOPEDICOS S/A

Brazil · Curitiba Parana

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

28listed device types

Class I 22Class II 6Class III 0

plus 29 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

56registered devices

Class I 49Class II 7

111 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

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 States29 registration records, 8 510(k), 0 PMA

Brazil56 confirmed, 0 excluded

Manufacturer names merged into this page: NEOORTHO PRODUTOS ORTOPEDICOS S/A · NEOORTHO PRODUTOS ORTOPÉDICOS S/A

FDA 510(k) clearances by year

12010 · K102641

12012 · K113733

42014 · K142419

12017 · K162874

12022 · K221021

FDA listed device types

showing 8 of 28

Rod, Fixation, Intramedullary And Accessories 1Screw, Fixation, Intraosseous 1Plate, Bone 1Plate, Fixation, Bone 1Screw, Fixation, Bone 1Washer, Bolt Nut 1Template 1Probe 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221021	Femoral Trochanteric Nail System Neonail	2022-12-06
US	K162874	Cannulated Screws Neoortho	2017-06-27
US	K142419	Mini and Micro Fragments Reconstruction System-NEOFIX	2014-12-16
BR	80546720080	Instrumental Articulado Cortante em Aço Inox	Class I
BR	80546720108	SISTEMA DE FIXAÇÃO EXTERNA PERTROCANTÉRICA NEOORTHO	Class I
BR	80546720111	Sistema de Fixação Externa Mini Neoortho 2	Class I

NEOORTHO PRODUTOS ORTOPEDICOS S/A

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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