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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
RIWOtrack Cube4D
Fiagon GmbH
·
,
Germany
Class IIa
FDA 510(k)
×5
K163209
Active
Cleared 14 Sep 2017
CE/MDR
+1
authorizations
Stealth AXiS Platforms
Medtronic Navigation, Inc.
·
,
United States
Class I
CE/MDR
GUDID
on market
EndoNaut (System)
Therenva Sas
·
,
France
Class IIb
CE/MDR
GUDID
on market
Navient
Claronav Kolahi
·
,
Canada
Class IIa
CE/MDD
GUDID
on market
PointerTube Kennedy
Fiagon GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
4K Navigation Unit Cube4D
Fiagon GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
FlexTube 4mm
Fiagon GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
Navigation Unit Cube4D
Fiagon GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
Micromate™ / Micromate™ Navi+
iSYS Medizintechnik GmbH
·
,
Austria
Class I
CE/MDR
RIWOtrack Flexsensor
Fiagon GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
Navident EVO Mount
Claronav
·
,
Canada
Class IIa
CE/MDR
Laser Robot Arm
ATLAS medical technologies GmbH
·
,
Germany
Class I
CE/MDR
Navigation Sensor
Fiagon GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
EndoNaut (Server) System
Therenva Sas
·
,
France
Class IIb
CE/MDR
Localizer Bone Anchor C-Type
Fiagon GmbH
·
,
Germany
Class IIa
CE/MDR
Localizer K-Wire
Fiagon GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
Navient
Claronav Kolahi
·
,
Canada
Class IIa
CE/MDR
CE/MDD
+1
authorizations
FlexTube 3mm
Fiagon GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
OTS™ Tracer PT
Ortoma AB
·
,
Sweden
Class I
CE/MDR
Arvis
Kico Knee Innovation Company Pty Limited
·
,
Australia
Class IIa
CE/MDR
GUDID
on market
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