FDA.reportPublic FDA data

Surgical planning/navigation-enhancement system

Definition
A mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.
GUDID devices
233
Last updated
2026-10-06 03:49:40

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
BN981BN002020Bolt NavigationCircinus Medical Technology LLCBN002-022026-09-25
BN981BN00202BX101Bolt NavigationCircinus Medical Technology LLCBN002-02BX102026-09-25
B981BN0010101Bolt NavigationCircinus Medical Technology LLCBN001-01-012023-03-15
B981BN00201103Bolt NavigationCircinus Medical Technology LLCBN002-01-102023-03-15
00885556918937NASmith & Nephew, Inc.722058102026-08-19
00885556918968NASmith & Nephew, Inc.722059112026-08-19
00885556924433TESSA ACL FEM LIC NO CLOUDSmith & Nephew, Inc.722057812026-08-14
00885556924440TESSASmith & Nephew, Inc.722057832026-08-14
00885556924457TESSASmith & Nephew, Inc.722057842026-08-14
00885556924464NASmith & Nephew, Inc.722057852026-08-14
00885556926680TESSASmith & Nephew, Inc.722057862026-08-14
00885556926703TESSASmith & Nephew, Inc.722057872026-08-14
00886874116272PlanPointINTUITIVE SURGICAL, INC.3807182019-03-21
07613327541809N/AStryker Leibinger GmbH & Co. KG6003-700-0002023-05-11
07613327542332N/AStryker Leibinger GmbH & Co. KG6003-710-0002023-05-11
07613327542868N/AStryker Leibinger GmbH & Co. KG6007-700-0002023-05-11
00886874116241IonINTUITIVE SURGICAL, INC.3807072019-03-21
00886874116234IonINTUITIVE SURGICAL, INC.3807482019-03-21
00817421021336X-GuideXNAV TECHNOLOGIES LLCP0103032021-01-25
00817421021350X-GuideXNAV TECHNOLOGIES LLCP0103042021-01-25
00817421021374X-GuideXNAV TECHNOLOGIES LLCP0103052021-01-25
00817421021398X-GuideXNAV TECHNOLOGIES LLCP0103062021-01-25
00817421021411X-GuideXNAV TECHNOLOGIES LLCP0103072021-01-25
00817421021435X-GuideXNAV TECHNOLOGIES LLCP0103082021-01-25
00817421022418X-GuideXNAV TECHNOLOGIES LLCP0085422023-01-30
00817421022500X-GuideXNAV TECHNOLOGIES LLCP0091542023-01-30
00817421022593X-GuideXNAV TECHNOLOGIES LLCP0082962023-01-30
00817421022609X-GuideXNAV TECHNOLOGIES LLCP0085422023-01-30
00817421022753X-GuideXNAV TECHNOLOGIES LLCP0085422024-09-05
03760262480039EndoNaut WorkstationTHERENVATS1CA2DS1-22026-05-06
03760262480046EndoNaut (System)THERENVA1.22026-05-06
03760262480084EndoNaut System MHSTHERENVA1.22026-05-06
B109VISAR2730VisARNovarad CorporationVisAR 2.732024-12-16
B109VISAR2880VisARNovarad CorporationVisAR 2.882025-06-24
B109VISAR30670VisARNovarad CorporationVisAR 3.0.672025-12-11
24719878713058Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-022025-01-13
B201CGSCENERGYTP0Clear Guide SCENERGY TPCLEAR GUIDE MEDICAL, INC.CGSCENERGYTP2025-01-10
00817421022920X-GuideXNAV TECHNOLOGIES LLCP0085422024-12-09
00817421023361X-GuideXNAV TECHNOLOGIES LLCP0085422024-12-09
04719878713016Disposable Passive SphereTaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-DPS-002024-12-03
14719878713112Bone DrillTaiwan Main Orthopaedic Biotechnology Co., Ltd.MSI-PDL-012024-12-03
24719878713065Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-022024-12-03
04719878713078HeadsetTaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-SSG-022024-12-02
04719878713085Connection SystemTaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-CNS-022024-12-02
04719878713207Disposable Passive SphereTaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-DPS-042024-12-02
04719878713337RouterTaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-RTR-022024-12-02
04719878713511Navigation CartTaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-NGC-032024-12-02
04719878713528Navi TrackerTaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-NTR-022024-12-02
04719878713542Navi TrackerTaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-NTR-042024-12-02
04719878713573Navi Tracker Mobile StanderTaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-NGC-042024-12-02
04719878713733Instrument HolderTaiwan Main Orthopaedic Biotechnology Co., Ltd.MSI-ITH-012024-12-02
04719878713801LaptopTaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-LTP-012024-12-02
14719878713099Minimally Invasive Spine Surgery InstrumentsTaiwan Main Orthopaedic Biotechnology Co., Ltd.MSI-022024-12-02
24719878713041Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.CDS-022024-12-02
BN981BN001021Bolt Navigation Circinus Medical Technology LLCBN001-022024-11-15
BN981BN002023Bolt Navigation Circinus Medical Technology LLCBN002-022024-11-15
00817421022791X-GuideXNAV TECHNOLOGIES LLCP0118032024-10-08
07350137520005OTS Hip PlanOrtoma AB (Publ)52024-10-01
00817421022784X-GuideXNAV TECHNOLOGIES LLCP0085422024-09-06
00817421022814X-GuideXNAV TECHNOLOGIES LLCP0085422024-09-06
00817421022821X-GuideXNAV TECHNOLOGIES LLCP0085422024-09-06
G67910Augmented Reality ApplicationSira Medical, Inc.12024-07-31
00817421022838X-GuideXNAV TECHNOLOGIES LLCP0085422024-06-24
07540209955006NavidentClaronav Inc955-ND-ND, plus kits2024-05-07
00817421022623X-GuideXNAV TECHNOLOGIES LLCP0108742024-03-15
00817421022630X-GuideXNAV TECHNOLOGIES LLCP0108692024-03-15
00817421022647X-GuideXNAV TECHNOLOGIES LLCP0108732024-03-15
08720299953703Neural Navigator Brain Science Tools B.V.10.12024-03-11
07540209955952NavidentClaronav Inc955-ND-HPTG-0002024-02-23
B109VISAR2150VisARNovarad CorporationVisAR 2.1.52024-02-12
00850049386029InliantNavigate Surgical Technologies Inc900007-02023-10-20
00817421022616X-GuideXNAV TECHNOLOGIES LLCP0108702023-09-20
00850049386111InliantNavigate Surgical Technologies Inc900010-12023-09-05
00860003884126SpineAR SNAPSURGICAL THEATER LLCSpineAR2023-06-23
00860003884102SyncAR SNAPSURGICAL THEATER LLCSyncAR2020-06-01
07540209955761NavidentClaronav Inc955-ND-TRTO (Version 3)2023-03-31
07540209955778NavidentClaronav Inc955-ND-JTVB2023-03-31
07540209955785NavidentClaronav Inc955-ND-JTVC2023-03-31
07540209955792NavidentClaronav Inc955-ND-JTVU2023-03-31
07540209955808NavidentClaronav Inc955-ND-JTTA-0002023-03-31