FDA.reportPublic FDA data

Multi-purpose stereotactic surgery system

Definition
An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.
GUDID devices
1,188
Last updated
2023-09-06 01:11:17

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000650827NAMEDTRONIC NAVIGATION, INC.97364642023-08-26
07640172552391VADER Pedicle System, Navigation Adaptericotec AG42-680N2023-08-10
00763000554293N/AMEDTRONIC NAVIGATION, INC.97364282022-10-24
00763000312275N/AMEDTRONIC NAVIGATION, INC.97362682022-08-21
00763000312282N/AMEDTRONIC NAVIGATION, INC.97362692022-08-21
00763000312299N/AMEDTRONIC NAVIGATION, INC.97362702022-08-21
00763000312305N/AMEDTRONIC NAVIGATION, INC.97362712022-08-21
00763000312312N/AMEDTRONIC NAVIGATION, INC.97362722022-08-21
00763000423094N/AMEDTRONIC NAVIGATION, INC.97349242022-08-11
00763000662257N/AMEDTRONIC NAVIGATION, INC.97344942022-08-11
00763000362416Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.296312022-08-05
00763000536244Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.256502022-08-05
00763000536251Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.280802022-08-05
00763000536268Stealth Autoguide™ SystemMEDTRONIC SOFAMOR DANEK, INC.286352022-08-05
00763000536275Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.291932022-08-05
00763000536282Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.294802022-08-05
00763000536299Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.294392022-08-05
00763000536305Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.304632022-08-05
00763000536312Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.97361912022-08-05
00763000536336Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.315272022-08-05
00763000536428Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.275652022-08-05
00763000571832Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.97361882022-08-05
00763000571856Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.97361892022-08-05
00763000631628Synergy®CranialMEDTRONIC NAVIGATION, INC.97337632022-07-07
03760244034793ROSA ONE SURGICAL ASSISTANT (US)MEDTECH3.1.62022-06-20
03760244034922PLANNING STATION-ROSA ONE- USAMEDTECH1640502022-06-20
03760244035127PLANNING STATION-ROSA ONE- USAMEDTECH1640502022-06-20
07640167222131CAS-One IRCAScination AG2.02022-06-10
00763000630072Stealth AutoguideMEDTRONIC NAVIGATION, INC.97364642022-05-08
00763000658656N/AMEDTRONIC NAVIGATION, INC.961-5742022-04-28
00850028694022HOLO PortalSurgalign Spine Technologies, Inc.1540000182022-04-28
00850028694084HOLO PortalSurgalign Spine Technologies, Inc.1540000212022-04-28
00850028694091HOLO PortalSurgalign Spine Technologies, Inc.1540000222022-04-28
00850028694107HOLO PortalSurgalign Spine Technologies, Inc.1540000232022-04-28
00850028694121HOLO PortalSurgalign Spine Technologies, Inc.1540000562022-04-28
00850028694145HOLO PortalSurgalign Spine Technologies, Inc.1540000802022-04-28
00850028694152HOLO PortalSurgalign Spine Technologies, Inc.1540000772022-04-28
00850028694169HOLO PortalSurgalign Spine Technologies, Inc.1540000782022-04-28
00850028694367HOLO PortalSurgalign Spine Technologies, Inc.1540000862022-04-28
00850028694374HOLO PortalSurgalign Spine Technologies, Inc.1540000872022-04-28
07290115751291Mazor X Navigation CameraMAZOR ROBOTICS LTDTPL0063-052022-04-15
00763000573263N/AMEDTRONIC NAVIGATION, INC.97312032022-04-02
00763000536329AutoguideMEDTRONIC NAVIGATION, INC.275632022-03-28
00763000571849Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.97361882022-03-17
00763000546205N/AMEDTRONIC NAVIGATION, INC.97344612022-02-26
00763000632779N/AMEDTRONIC NAVIGATION, INC.9735547ENT2022-02-25
03760244034625SEEG DRILL ADAPTOR Ø2.5MMMEDTECH1741532022-02-18
03760244034632SEEG DRILL ADAPTOR Ø2.15MMMEDTECH1741532022-02-18
03760244034649SEEG DRILL ADAPTOR Ø2.45MMMEDTECH1741532022-02-18
03760244034656SEEG DRILL ADAPTOR Ø2.55MMMEDTECH1741532022-02-18
03760244034663SEEG DRILL ADAPTOR Ø3.2MMMEDTECH1741532022-02-18
00763000531539SteathStationMEDTRONIC NAVIGATION, INC.97357442022-01-29
00763000531546SteathStationMEDTRONIC NAVIGATION, INC.97358952022-01-29
00763000531973SteathStationMEDTRONIC NAVIGATION, INC.97360252022-01-29
00763000532123SteathStationMEDTRONIC NAVIGATION, INC.97357622022-01-29
EFIAE0030010Adhesive PadIntersect ENT GmbH12022-01-21
EFIAE0110081Navigation Headrest OfficeFiagon GmbH12022-01-22
00763000536343Stealth Autoguide™ SystemMEDTRONIC NAVIGATION, INC.282482022-01-17
EFIAE0111060Fiagon Navigation UnitFiagon GmbHCUBE4D2020-05-12
00763000381127N/AMEDTRONIC NAVIGATION, INC.97339772022-01-13
00763000588397AxiEM™MEDTRONIC NAVIGATION, INC.97350152021-12-30
00763000588403AxiEM™MEDTRONIC NAVIGATION, INC.97350162021-12-30
00763000588410AxiEM™MEDTRONIC NAVIGATION, INC.97350172021-12-30
00763000588427AxiEM™MEDTRONIC NAVIGATION, INC.97350182021-12-30
00763000588434AxiEM™MEDTRONIC NAVIGATION, INC.97350192021-12-30
00763000574109N/AMEDTRONIC NAVIGATION, INC.97334692021-12-03
00763000579005N/AMEDTRONIC NAVIGATION, INC.97338522021-12-04
00763000585624N/AMEDTRONIC NAVIGATION, INC.97359602021-12-03
00763000497965N/AMEDTRONIC NAVIGATION, INC.97325012021-11-25
00763000561987N/AMEDTRONIC NAVIGATION, INC.97300272021-11-07
00763000573256N/AMEDTRONIC NAVIGATION, INC.97344952021-11-01
00763000547103N/AMEDTRONIC NAVIGATION, INC.9732501XOM2021-10-15
00763000053536N/AMEDTRONIC NAVIGATION, INC.97338792021-09-30
17290113780986XVS STERILE COMPONENTS KITAUGMEDICS LTDASP000512021-09-05
00763000564094N/AMEDTRONIC NAVIGATION, INC.97356072021-08-16
00763000384234N/AMEDTRONIC NAVIGATION, INC.97361462021-08-13
00763000533120N/AMEDTRONIC NAVIGATION, INC.97327762021-08-15
00763000533137N/AMEDTRONIC NAVIGATION, INC.97327782021-08-15
00763000533144N/AMEDTRONIC NAVIGATION, INC.97327792021-08-15
00763000533151N/AMEDTRONIC NAVIGATION, INC.97327802021-08-15