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
67
Last updated
2026-09-04 23:12:53

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04056481006525Em Disposable StyletBrainlab SE180972018-02-08
04056481132422Navigation SW Cranial EMBrainlab SE1.12017-08-09
04056481142520Curve Navigation 17700Brainlab SE177002020-05-25
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
00841690195382OMNIBoticsOmni Life Science, Inc.NV-CRT012023-01-10
00841690195399OMNIBoticsOmni Life Science, Inc.NV-CAM012023-01-10
00889095366631EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.27022019-07-31
00889095740912EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.25422018-06-27
00889095782455CREOGLOBUS MEDICAL, INC.6200.10902019-07-31
00889095782462CREOGLOBUS MEDICAL, INC.6200.10952019-07-31
00889095782479CREOGLOBUS MEDICAL, INC.6200.14002019-08-01
00889095782486CREOGLOBUS MEDICAL, INC.6200.14052019-08-01
07613327628357RPSSTRYKER CORPORATION88080000002025-10-01
07649998256025Dynamis Robotic Surgical System LEM Surgical AGTPL00012025-10-14
08908002051063MAXIOPERFINT HEALTHCARE PRIVATE LIMITEDV22018-05-04
10885862144195EXACTECHGPSExactech, Inc.J000102017-12-18
10885862144218EXACTECHGPSExactech, Inc.J000112017-12-18
10885862144225EXACTECHGPSExactech, Inc.K000012017-12-18
10885862144256EXACTECHGPSExactech, Inc.A100032017-12-18
10885862144263EXACTECHGPSExactech, Inc.A100042017-12-18
10885862144270EXACTECHGPSExactech, Inc.A100062017-12-18
10885862144287EXACTECHGPSExactech, Inc.A100052017-12-18
10885862144294EXACTECHGPSExactech, Inc.A100072017-12-18
10885862252821EXACTECHGPSExactech, Inc.I000202017-12-18
10885862266651EXACTECHGPSExactech, Inc.A100122017-12-18
10885862266668EXACTECHGPSExactech, Inc.I000212017-12-18
10885862266675EXACTECHGPSExactech, Inc.I000222017-12-18
10885862518767EXACTECHGPSExactech, Inc.L000412017-12-18
10885862518927EXACTECHGPSExactech, Inc.J000202017-12-18
10885862553331EXACTECHGPSExactech, Inc.J001202020-10-05
10885862574091EXACTECHGPSExactech, Inc.I000252020-10-05