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LINCOTEK MEDICAL, LLC

USA · Bartlett

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, South Korea, Australia, Israel — 6 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

42listed device types

Class I 13Class II 27Class III 2

plus 62 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

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

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIa 1

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 States62 registration records, 2 510(k), 0 PMA, 3 excluded

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: Lincotek Medical · LINCOTEK MEDICAL, LLC · Lincotek Medical LLC · LINCOTEK MEDICAL

FDA 510(k) clearances by year

12025 · K250764

12026 · K252081

FDA listed device types

showing 8 of 42

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) 1Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) 1Electrode, Needle 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Screw, Fixation, Bone 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252081	SportLinc Syndesmosis Device	2026-03-27
US	K250764	SpineLinc Anterior Cervical Implant System	2025-12-05
BR	80005430598	Instrumentais Estéreis para Implante em Aço Inoxidável Stryker	Class II
BR	80005430598	Instrumentais Estéreis para Implante em Aço Inoxidável Stryker	Class II
BR	80005430615	Passador de Sutura Champion	Class I

LINCOTEK MEDICAL, LLC

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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