OSTEONIC CO., LTD.

Korea, Republic · Seoul

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Israel, Russia — 7 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

30listed device types

Class I 18Class II 12Class III 0

plus 38 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

18registered devices

Class I 17Class II 1

34 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

12valid device licences

Class I 3Class II 8Class III 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

25active ARTG entries

Class I 13Class III 4IIa 2IIb 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 States38 registration records, 20 510(k), 0 PMA

Brazil18 confirmed, 0 excluded

Manufacturer names merged into this page: OSTEONIC CO., LTD. · OSTEONIC CO LTD

FDA 510(k) clearances by year

22015

12016

22019

12020

52021

12022

32023

32024

12025

12026

FDA listed device types

showing 8 of 30

Instrument, Bending Or Contouring 1Screwdriver 1Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment 1Forceps 1Chisel, Surgical, Manual 1Gauge, Depth 1Bit, Drill 1Retractor 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254182	Aster	2026-02-26
US	K243469	SIGNEX	2025-05-29
US	K243470	Fix2Lock (PEEK Self Punching)	2024-12-03
BR	80136991009	Instrumental Neuro Plating System	Class I
BR	82871490006	Optimus Angled Screwdriver	Class I
BR	82042500017	Fio guia de uso único	Class I

OSTEONIC CO., LTD.

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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