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THE ORTHOPAEDIC IMPLANT COMPANY

USA · Reno

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Singapore — 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

10listed device types

Class I 2Class II 8Class III 0

plus 19 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

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

4device registrations

CLASS C 4

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 States19 registration records, 16 510(k), 0 PMA, 45 excluded

Brazil0 confirmed, 15 excluded

Saudi Arabia0 confirmed, 6 excluded

Manufacturer names merged into this page: THE ORTHOPAEDIC IMPLANT COMPANY

FDA 510(k) clearances by year

12012

12013

12014

12015

12016

12017

22018

12019

22021

12022

22023

22024

FDA listed device types

showing 8 of 10

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Rod, Fixation, Intramedullary And Accessories 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Plate, Fixation, Bone 1Intervertebral Fusion Device With Bone Graft, Cervical 1Screw, Fixation, Bone 1Fastener, Fixation, Nondegradable, Soft Tissue 1Washer, Bolt Nut 1

Market	Identifier	Name	Class / date
US	K242995	OIC Small / Mini Fragment Plate System	2024-10-23
US	K233531	OIC FLEX-FIX System	2024-02-02
US	K223761	OIC Intramedullary Screw System	2023-02-13

THE ORTHOPAEDIC IMPLANT COMPANY

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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