Home›USA›Osteomed Corp.

Osteomed Corp.

USA · Addison

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel — 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

59listed device types

Class I 35Class II 23Class III 0unclassified 1

plus 100 registration records and 73 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 3Class II 2

15 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 1Class III 3

20 including historic records

TWTaiwanTFDA

31valid device licences

Class I 4Class II 26Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

9active ARTG entries

Class I 1IIa 2IIb 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States100 registration records, 73 510(k), 0 PMA, 3 excluded

Brazil5 confirmed, 2 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: OSTEOMED · OSTEOMED LLC.

FDA 510(k) clearances by year

62002

52003

22004

12005

42006

32007

32008

22009

22010

22011

32012

52013

32014

42015

12016

32017

12018

22020

12021

12022

FDA listed device types

showing 8 of 59

Prosthesis, Toe, Constrained, Polymer 1Prosthesis, Condyle, Mandibular, Temporary 1Screw, Fixation, Bone 1Implant, Endosseous, Root-Form 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Washer, Bolt Nut 1System, Image Processing, Radiological 1Driver, Wire, And Bone Drill, Manual 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212570	OsteoPlan System	2022-02-11
US	K203479	ExtremiLOCK Lateral Ankle Fusion Plates	2021-02-24
US	K202105	OsteoMed ExtremiFix Mini & Small System Tray	2020-10-29
BR	10247530215	Instrumentais M6-L Osteomed	Class I
BR	10247530216	Instrumentais M6-C Osteomed	Class I
BR	10247530164	FAMÍLIA DE INSTRUMENTAL NÃO ARTICULADO CORTANTE DESCARTÁVEL OSTEOMED	Class II
CA	12394	QUICK-FIX FIXATION SYSTEM	Class III
CA	12396	TRAM FIXATION SYSTEM	Class III
CA	89867	SILICONE TUBING SLEEVE	Class II

Osteomed Corp.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies