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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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General and multidisciplinary surgery instruments
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Surgical navigation instruments
Surgical navigation instruments
Z120114
711 devices
Subcategories
5
Z12011401
Surgical navigation system
96
devices
Z12011480
Surgical navigation instruments - hardware accessories
443
devices
Z12011482
Surgical navigation instruments - software accessories
34
devices
Z12011485
Surgical navigation instruments - consumables
117
devices
Z12011492
Surgical navigation instruments - medical device software
21
devices
Devices
Robio Ex
Perfint Healthcare Pvt Ltd
·
,
IN
Class IIa
CE/MDD
NaoTrac
Brain Navi Biotechnology Co., Ltd.
·
,
TW
Class IIb
CE/MDD
Robin Navigation Unit
Orthokey Italia SRL
·
,
IT
Class IIa
CE/MDR
IT348354
Active
Valid to Dec 2030
Robotic-guided Orthopedic Surgical System
TINAVI Medical Technologies Co., Ltd.
·
,
CN
Class IIb
CE/MDR
IGI Anterior MINILOCK
Image Navigation Ltd
·
,
IL
Class IIa
CE/MDR
28620157982
Active
Valid to Feb 2028
IGI Posterior MINILOCK
Image Navigation Ltd
·
,
IL
Class IIa
CE/MDR
28620157982
Active
Valid to Feb 2028
Maxio
Perfint Healthcare Pvt Ltd
·
,
IN
Class IIa
FDA 510(k)
K132108
Active
Cleared 19 May 2014
CE/MDD
+1
authorizations
Dental Implant Navigation Equipment
Suzhou Digital-health Care Co. Ltd.
·
,
CN
Class IIa
CE/MDR
Stealth AXiS Platforms
Medtronic Navigation, Inc.
·
,
US
Class I
CE/MDR
Localizer Adhesive Pad C-Type
Fiagon GmbH
·
,
DE
Class IIa
CE/MDR
GUDID
on market
OTS™ Tracer CB
Ortoma AB
·
,
SE
Class I
CE/MDR
Perseus Device Sensor
Orthokey Italia SRL
·
,
IT
Class I
FDA 510(k)
K192653
Active
Cleared 9 Sep 2020
CE/MDD
+1
authorizations
FlexPointer
Fiagon GmbH
·
,
DE
Class IIa
CE/MDR
GUDID
on market
Stealth AXiS Platforms
Medtronic Navigation, Inc.
·
,
US
Class I
CE/MDR
Xgk-6508B
Shenzhen Futurtec Medical Co.，LTD.
·
,
CN
Class IIb
CE/MDR
Dynamic Navigation system
Institut Straumann AG
·
,
CH
Class IIa
CE/MDR
IMACTIS Navigation station
Imactis SAS
·
,
FR
Class IIb
CE/MDR
Stealth AXiS Platforms
Medtronic Navigation, Inc.
·
,
US
Class I
CE/MDR
EndoNaut (System) MHS2 (Mobile Hybrid Solution)
Therenva Sas
·
,
FR
Class IIb
CE/MDR
Autopilot Tool Changer
Medtronic Navigation, Inc.
·
,
US
Class I
CE/MDR
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