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K2m, Incorporated

USA · Leesburg

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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

46listed device types

Class I 24Class II 20Class III 1unclassified 1

plus 154 registration records and 127 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

55registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

32 including historic records

TWTaiwanTFDA

8valid device licences

Class I 2Class II 6

SGSingaporeHSA SMDR

28device registrations

CLASS B 7CLASS C 21

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

38active ARTG entries

Class I 8IIa 17IIb 9Class Im (measuring) 4

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

8registrations

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 States154 registration records, 127 510(k), 0 PMA

Saudi Arabia55 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: K2M, INC. · K2M, Inc.

FDA 510(k) clearances by year

42005

22006

32007

82008

52009

62010

102011

112012

92013

122014

142015

102016

102017

122018

32019

42020

12022

32026

FDA listed device types

showing 8 of 46

Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Cerclage, Fixation 1Intervertebral Fusion Device With Integrated Fixation, Cervical 1Appliance, Fixation, Spinal Interlaminal 1Bone Fixation Cerclage, Sublaminar 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260546	Q Pedicle Instruments	2026-03-17
US	K253545	Vulcan Spinal System	2026-02-10
US	K252873	Q Interbody Instruments	2026-02-06
SA	ME0000002133SFDAA00191	EVEREST® Spinal System	—
SA	ME0000000432SFDAA00058	MESA® Spinal System, Overhead Reamer	—
CA	104630	BONE FUNNEL	Class II

K2m, Incorporated

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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