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Stryker Leibinger GmbH & Co. KG - Navigation

Germany · Freiburg

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

77listed device types

Class I 31Class II 43Class III 2unclassified 1

plus 183 registration records and 38 510(k), 35 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class I 11Class II 5

33 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

23active device licences

Class II 12Class III 11

104 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

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 States183 registration records, 38 510(k), 35 PMA, 7 excluded

Brazil16 confirmed, 0 excluded

Canada23 confirmed, 0 excluded

Manufacturer names merged into this page: STRYKER LEIBINGER GMBH & CO. KG · STRYKER LEIBINGER · STRYKER LEIBINGER GMBH & CO. KG.

Same-named companies — This database also contains companies with near-identical names: STRYKER LEIBINGER GMBH & CO. KG., Stryker Leibinger Micro Implants. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11999

32000

12001

12002

22003

22004

32005

12009

12010

22014

12015

12016

12018

12019

32022

42023

62024

42026

FDA listed device types

showing 8 of 77

Electrosurgical, Cutting & Coagulation & Accessories 1Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Rod, Fixation, Intramedullary And Accessories 1Prosthesis, Condyle, Mandibular, Temporary 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Screw, Fixation, Bone 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1Neurological Stereotaxic Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261054	RibPlate System	2026-07-01
US	K254233	MEDPOR Customized Implant Kit	2026-03-12
US	K253623	Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor	2026-02-19
BR	80005430392	Instrumental Stryker não Articulado não Cortante Orthopaedics	Class I
BR	80005430206	INSTRUMENTAL CMF III	Class I
BR	80005430048	PINÇAS CONQUEST DE APRENSAO PARA CIRURGIAS ARTROSCOPICAS STRYKER	Class II
CA	11917	BONE SOURCE CLASSIC	Class III
CA	15731	LEIBINGER DISTRACTION SYSTEMS	Class III
CA	27687	TITANIUM OSSICULAR REPLACEMENT SYSTEM	Class III

Stryker Leibinger GmbH & Co. KG - Navigation

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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