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Ortho Development Corporation

USA · Draper

✓ 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

54listed device types

Class I 28Class II 26Class III 0

plus 91 registration records and 64 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 4Class II 1

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class IV 1

2 including historic records

TWTaiwanTFDA

0valid device licences

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 States91 registration records, 64 510(k), 0 PMA, 109 excluded

Brazil5 confirmed, 34 excluded

Saudi Arabia0 confirmed, 12 excluded

Canada1 confirmed, 12 excluded

Manufacturer names merged into this page: ORTHO DEVELOPMENT CORP. · ORTHO DEVELOPMENT CORPORATION · ORTHO CLINICAL DIAGNOSTICS BIOTECHNOLOGY DEVELOPMENT (SHANGHAI) CO., LTD.

FDA 510(k) clearances by year

22000

12001

22002

12003

52005

52006

32007

12009

42011

52013

52014

12015

22016

22017

42018

12020

32021

12023

32024

22025

FDA listed device types

showing 8 of 54

Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Screw, Fixation, Bone 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous 1Appliance, Fixation, Spinal Interlaminal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253161	Balanced Knee System TriMax Porous Femoral Components	2025-12-19
US	K251052	Trivicta® Hip Stem	2025-05-22
US	K242984	BKS Revision System	2024-10-25
BR	80202250007	INSTRUMENTAIS PARA IMPLANTE CERVICAL ENVISION²	Class I
BR	80202250033	INSTRUMENTAL PARA IMPLANTE CERVICAL ENVISION²	Class I
BR	80202250032	Instrumental Pagoda	Class I
CA	64461	ORION-1 EMF SYSTEM	Class IV

Ortho Development 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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