FDA.reportPublic FDA data

Robotic surgical navigation system

Definition
An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It typically consists of an operator's console featuring a robotic surgical arm(s) and a video camera used to track the robotic instrumentation. The input to the computer is usually by means of an existing CT or MRI scan. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.
GUDID devices
107
Last updated
2026-11-01 02:54:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00889024563483iASSIST®Orthosoft Inc20-8011-070-242020-01-14
00889024563490iASSIST®Orthosoft Inc20-8011-070-192020-01-14
00887868523885ROSA® HipOrthosoft Inc20-8060-400-002021-08-24
00889024478954Sesamoid Plasty V2 StandOrthosoft Inc20-8000-070-802016-12-21
00889024478961Camera KitOrthosoft Inc20-8000-070-992016-12-21
00889024478978Sesamoid Plasty V2 Computer KitOrthosoft Inc20-8000-070-772016-12-21
00889024492769OpticalOrthosoft Inc20-8000-070-462017-09-12
00887868558467iASSIST® Knee SystemOrthosoft Inc302.40212022-09-21
00887868558474iASSIST® Knee SystemOrthosoft Inc20-8011-900-132022-09-21
00889024305083OpticalOrthosoft Inc20-8000-070-352016-09-12
00889024305090SesamoidOrthosoft Inc20-8000-070-362016-09-12
00889024305106SesamoidOrthosoft Inc20-8000-070-372016-09-12
00889024305113SesamoidOrthosoft Inc20-8000-070-382016-09-12
00889024305120SesamoidOrthosoft Inc20-8000-070-392016-09-12
03760305400246DUAL SIDED NEEDLE GUIDEQUANTUM SURGICAL30-00032026-10-19
03760305400277PATIENT REFERENCE 2.0QUANTUM SURGICAL30-00022026-10-19
04056481004507Base Short For DrapelinkBrainlab SE19153-042016-09-15
04056481004514Base Long For DrapelinkBrainlab SE19153-032016-09-15
04056481004521Adapter For Doro Skull ClampBrainlab SE19153-022016-09-15
04056481004538Adapter For Mayfield Skull ClampBrainlab SE19153-012016-09-15
04056481004545Cranial Reference Array DrapelinkBrainlab SE19152-022016-09-15
04056481004552Interconnector DrapelinkBrainlab SE19152-012016-09-15
04056481004569Calibration Phantom IctBrainlab SE19148-01A2016-09-15
04056481004637Drapelink Interface Ict Calib PhantomBrainlab SE19142-062016-09-15
04056481006655Kick 2 Navigation StationBrainlab SE181702016-11-25
04056481138011Curve 1.2 Dual Navigation StationBrainlab SE19901A2018-01-04
04056481142520Curve Navigation 17700Brainlab SE177002020-05-25
04056481142742Spine Reference Adapter, LongBrainlab SE55761-02A2022-04-28
04056481143114Drill Bit 2.6 mm AO Shank Depth ControlBrainlab SE41839-65A2022-04-28
04056481143176Drill Bit 2.6 mm AO ShankBrainlab SE41839-69A2022-04-28
04056481143183Drill Bit 2.6 mm Depth Control (200 mm)Brainlab SE41839-68A2022-04-28
04056481143190Drill Bit 4.5 mm AO ShankBrainlab SE41839-45A2022-04-28
04056481143206Drill Bit 3.2 mm Depth Control (200 mm)Brainlab SE41839-37A2022-04-28
04056481143213Drill Bit 3.2 mm AO Shank Depth ControlBrainlab SE41839-36A2022-04-28
04056481143220Drill Bit 3.2 mm AO ShankBrainlab SE41839-35B2022-04-28
04056481143237Drill Bit 2.4 mm AO ShankBrainlab SE41839-29A2022-04-28
04056481143244Drill Bit 2.4 mm AO Shank Depth ControlBrainlab SE41839-28A2022-04-28
07613327631814RPSStryker Leibinger GmbH & Co. KG88008000002025-10-03
04056481002152Bl Pointer Straight-ExtendedBrainlab SE52781A2016-09-15
04056481002374Bone Fixator 1-Pin, X-Press Size-SBrainlab SE52421B2016-09-15
04056481002404Reference Array T-Geometry, X-PressBrainlab SE52410A2016-09-15
04056481006525Em Disposable StyletBrainlab SE180972018-02-08
04056481132422Navigation SW Cranial EMBrainlab SE1.12017-08-09
07649998256704Dynamis Robotic Surgical SystemLEM Surgical AGTPL0001-042026-07-07
10810068810858MONARCH™ ControllerAuris Health, Inc.MON-0007062026-05-27
00850030914002N/AMicroport Navibot International LLC10016NB2023-01-19
00850030914019N/AMicroport Navibot International LLC10012NB2023-01-18
04056481138769Elements Trajectory PlanningBrainlab SE2.02017-06-14
04719881650117POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSNF01-0002026-04-09
04719881650919POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-4012026-04-10
04719881650926POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-4022026-04-09
04719881650933POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-4032026-04-09
04719881650940POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-4042026-04-09
04719881650957POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-4052026-04-09
04719881650964POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-4062026-04-09
04719881650971POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-4072026-04-09
04719881650988POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-4082026-04-09
04719881650995POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-4092026-04-09
04719881651008POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-1A12026-04-09
04719881651015POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-2A12026-04-09
04719881651022POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-2012026-04-09
04719881651039POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-2022026-04-09
04719881651152POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-2032026-04-09
04719881651169POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-2042026-04-09
04719881651176POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-2052026-04-09
04719881651183POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-2062026-04-09
04719881651190POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-2072026-04-09
04719881651206POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-2082026-04-09
04719881651862POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-2A22026-04-09
04719881651879POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSSS01-207S2026-04-09
00193982622312EXCELSIUSGPSGLOBUS MEDICAL, INC.6252.00482026-03-24
00193982622329EXCELSIUSGPSGLOBUS MEDICAL, INC.6252.00492026-03-24
00841690194057OMNIBoticsOmni Life Science, Inc.NV-LPT032023-01-10
00841690194064OMNIBoticsOmni Life Science, Inc.NV-LPT022023-01-10
00841690194071OMNIBoticsOmni Life Science, Inc.NV-CRT072023-01-10
00841690194095OMNIBoticsOmni Life Science, Inc.NV-CAS022023-01-10
00841690194101OMNIBoticsOmni Life Science, Inc.NV-CAS012023-01-10
00841690194873OMNIBoticsOmni Life Science, Inc.NV-CRD032023-01-10
00841690194880OMNIBoticsOmni Life Science, Inc.NV-CRD022023-01-10
00841690194897OMNIBoticsOmni Life Science, Inc.NV-CRD012023-01-10