FDA.reportPublic FDA data

Orthopaedic 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 orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.
GUDID devices
796
Last updated
2026-10-06 03:50:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810076335322MomentumUlrich Medical Usa, Inc.UU062-94-01002026-09-25
10888857563384Q Interbody InstrumentsVB Spine LLC8020-900202026-03-03
10888857563391Q Interbody InstrumentsVB Spine LLC8020-900212026-03-03
10888857563407Q Interbody InstrumentsVB Spine LLC8020-900222026-03-03
10888857563414Q Interbody InstrumentsVB Spine LLC8020-900232026-03-03
10888857563421Q Interbody InstrumentsVB Spine LLC8020-900242026-03-03
10888857578975Q Interbody InstrumentsVB Spine LLC8020-900172026-03-03
00885556919897NASmith & Nephew, Inc.722058022026-08-19
00885556919965NASmith & Nephew, Inc.722057772026-08-19
00885556919972NASmith & Nephew, Inc.722057782026-08-19
00885556919989NASmith & Nephew, Inc.722057902026-08-19
00885556919996NASmith & Nephew, Inc.722057912026-08-19
00885556920008NASmith & Nephew, Inc.722057922026-08-19
00885556920015NASmith & Nephew, Inc.722057932026-08-19
00885556920022NASmith & Nephew, Inc.722058002026-08-19
00885556920039NASmith & Nephew, Inc.722058012026-08-19
00885556920046NASmith & Nephew, Inc.722057822026-08-19
00885556920053NASmith & Nephew, Inc.722058032026-08-19
10885862310033GPSExactech, Inc.521-30-062022-07-28
00850084604003OptiVu Shoulder Adapter HandleMR Surgical Solutions LLCOVMR-HW-2-03122026-06-03
00850084604010OptiVu Shoulder Pin InserterMR Surgical Solutions LLCOVMR-HW-2-03202026-06-03
00850084604027OptiVu Shoulder Cut GuideMR Surgical Solutions LLCOVMR-HW-2-03212026-06-03
00850084604034OptiVu Shoulder StylusMR Surgical Solutions LLCOVMR-HW-2-03242026-06-03
00850084604041OptiVu Shoulder Reaming GuideMR Surgical Solutions LLCOVMR-HW-2-03282026-06-03
00850084604058OptiVu Shoulder Clocking GuideMR Surgical Solutions LLCOVMR-HW-2-03442026-06-03
00850084604065OptiVu Shoulder Humeral Reference RodMR Surgical Solutions LLCOVMR-HW-2-03342026-06-03
00850084604072OptiVu Shoulder Scapular Reference RodMR Surgical Solutions LLCOVMR-HW-2-03312026-06-03
00850084604089OptiVu Shoulder Sterile TrayMR Surgical Solutions LLCOVMR-TR-2-00012026-06-03
00850084604096OptiVu Shoulder Software ApplicationMR Surgical Solutions LLCOVMR-SW-2-03102026-06-03
00850084604102OptiVu Shoulder Humeral GaugeMR Surgical Solutions LLCOVMR-HW-2-03222026-06-03
00850084604119OptiVu Shoulder Tracker KitMR Surgical Solutions LLCOVMRHL2-0102026-06-03
00850084604126OptiVu Shoulder Scapula Anchor PinMR Surgical Solutions LLCOVMRHL2-0122026-06-03
00810076338286Cortium NavigationUlrich Medical Usa, Inc.UU076-11-00302026-05-30
00810076338293Cortium NavigationUlrich Medical Usa, Inc.UU076-11-00352026-05-30
00810076338309Cortium NavigationUlrich Medical Usa, Inc.UU076-11-00402026-05-30
00810076338316Cortium NavigationUlrich Medical Usa, Inc.UU076-21-00102026-05-30
00810076338323Cortium NavigationUlrich Medical Usa, Inc.UU076-21-00202026-05-30
00810076338361Cortium NavigationUlrich Medical Usa, Inc.UU076-15-00242026-05-30
00810076338385Cortium NavigationUlrich Medical Usa, Inc.UU076-15-00302026-05-30
00810076338392Cortium NavigationUlrich Medical Usa, Inc.UU076-15-00312026-05-30
00810076338415Cortium NavigationUlrich Medical Usa, Inc.UU076-20-11012026-05-30
00810076338422Cortium NavigationUlrich Medical Usa, Inc.UU076-20-12012026-05-30
00810076338446Cortium NavigationUlrich Medical Usa, Inc.UU073-76-002026-05-30
00810076338552Cortium NavigationUlrich Medical Usa, Inc.UU076-14-01072026-05-30
00810076339443Cortium NavigationUlrich Medical Usa, Inc.UU076-20-21012026-05-30
00810076339450Cortium NavigationUlrich Medical Usa, Inc.UU076-20-22012026-05-30
00885556325490TRIGENSmith & Nephew, Inc.716911652015-09-28
00885556325544TRIGENSmith & Nephew, Inc.716911662015-09-28
03760297030490KneePlusPIXEE MEDICALKnee+2026-05-27
10885862656117NewtonExactech, Inc.02-521-90-20042026-05-27
10885862656124NewtonExactech, Inc.02-521-90-20052026-05-27
10885862656131NewtonExactech, Inc.02-521-90-20062026-05-27
10885862656148NewtonExactech, Inc.02-521-90-20072026-05-27
10885862656155NewtonExactech, Inc.02-521-90-20082026-05-27
10885862656162NewtonExactech, Inc.02-521-90-20092026-05-27
10885862656179NewtonExactech, Inc.02-521-90-20102026-05-27
00628184002100intellijoint HIP®Intellijoint Surgical Inc000-02102020-11-17
00628184005705Intellijoint KNEE®Intellijoint Surgical Inc000-05702026-03-18
00628184007907Intellijoint Navigation SystemIntellijoint Surgical Inc000-07902025-11-04
00628184007914Intellijoint Navigation SystemIntellijoint Surgical Inc000-07912025-11-04
00628184007976Intellijoint Navigation SystemIntellijoint Surgical Inc000-07972025-11-04
00628184007983Intellijoint Navigation SystemIntellijoint Surgical Inc000-07982025-11-04
00628184009604Intellijoint Navigation SystemIntellijoint Surgical Inc000-09602025-11-04
00628184009611Intellijoint Navigation SystemIntellijoint Surgical Inc000-09612025-11-04
00628184009628Intellijoint Navigation SystemIntellijoint Surgical Inc000-09622025-11-04
00763000457211Medtronic NavigationMEDTRONIC NAVIGATION, INC.97357402021-04-10
00763000457228Medtronic NavigationMEDTRONIC NAVIGATION, INC.97357402021-04-10
00763000457235Medtronic NavigationMEDTRONIC NAVIGATION, INC.97357402021-04-10
00763000457242Medtronic NavigationMEDTRONIC NAVIGATION, INC.97357402021-04-10
00763000457259Medtronic NavigationMEDTRONIC NAVIGATION, INC.97357402021-04-10
00763000457433Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359192021-04-10
00763000457440Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359192021-04-10
00763000457457Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359192021-04-10
00763000457464Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359192021-04-10
00763000457471Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359192021-04-10
00763000457488Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359192021-04-10
00763000457495Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359192021-04-10
00858704006008KneeAlign 2Orthalign, Inc.1336312016-09-23
03760297030322KneePlusPIXEE MEDICALKnee+2024-12-10
04719881650070POINT ROBOTICS MEDTECH INC.POINT ROBOTICS MEDTECH INC.PSHF01-0002026-04-09