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UNITED ORTHOPEDIC CORPORATION

Taiwan · Hsinchu

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, South Korea, Australia, Russia — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

32listed device types

Class I 14Class II 18Class III 0

plus 164 registration records and 60 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class I 18Class II 1

28 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1IIa 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 1 1Class 2b 2

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 States164 registration records, 60 510(k), 0 PMA, 79 excluded

Brazil19 confirmed, 11 excluded

Saudi Arabia0 confirmed, 11 excluded

Manufacturer names merged into this page: UNITED ORTHOPEDIC CORPORATION · UNITED ORTHOPEDIC CORP. · United Orthopedic Corporation

FDA 510(k) clearances by year

22005

12006

12007

22008

22010

52011

32012

72013

42014

32015

32016

72017

12018

22019

12020

12021

22022

22023

22024

52025

FDA listed device types

showing 8 of 32

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1Appliance, Fixation, Spinal Intervertebral Body 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Orthosis, Spinal Pedicle Fixation 1Orthosis, Spondylolisthesis Spinal Fixation 1Plate, Fixation, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252725	Stem Extension Line (U2 Total Knee SystemPSA Type)	2025-09-25
US	K252303	Stem Extension Line (USTAR II System)	2025-08-22
US	K243656	U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella	2025-07-31
BR	80794390018	Kit do Guia Instrumental AIO	Class I
BR	80794390087	Instrumento Cirúrgico Ortopédico Contentor de Líquido Criogênico - Cry	Class I
BR	80794390051	Kit Instrumental Base Tibial - CMA	Class I

UNITED ORTHOPEDIC CORPORATION

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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