FDA.reportPublic FDA data

Neurological 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 neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.
GUDID devices
2,184
Last updated
2026-11-01 02:54:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00873263003039WayPoint™ Indexing RingFHC, INC.66-MP-IR-003032016-09-17
07340201503829Leksell Neurosurgical InstrumentsElekta Solutions AB10404292026-10-20
07340201503836Leksell Neurosurgical InstrumentsElekta Solutions AB10404092026-10-20
07340201503843Leksell Neurosurgical InstrumentsElekta Solutions AB10404082026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions AB10404182026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions AB10404612026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions AB10404042026-10-19
00860001580907SIS SystemSurgical Information Sciences Inc.6.X.X, 7.X.X2021-06-03
06974813832681NASinovation (Beijing) Medical Technology Co., LtdGUD-CR-G2026-09-29
06974813832698NASinovation (Beijing) Medical Technology Co., LtdGUD-DBS-AO2026-09-29
06974813832704NASinovation (Beijing) Medical Technology Co., LtdGUD-DBS-LP2026-09-29
06974813832711NASinovation (Beijing) Medical Technology Co., LtdTT-2.2-302026-09-29
06974813832728NASinovation (Beijing) Medical Technology Co., LtdTT-2.2-702026-09-29
06974813832735NASinovation (Beijing) Medical Technology Co., LtdTT-2.5-702026-09-29
06974813832742NASinovation (Beijing) Medical Technology Co., LtdTT-5.0-652026-09-29
06974813832759NASinovation (Beijing) Medical Technology Co., LtdTT-50-30D2026-09-29
06974813832766NASinovation (Beijing) Medical Technology Co., LtdTT-50-40D2026-09-29
06974813832773NASinovation (Beijing) Medical Technology Co., LtdTT-50-50D2026-09-29
06974813832780NASinovation (Beijing) Medical Technology Co., LtdTT-50-35D2026-09-29
06974813832797NASinovation (Beijing) Medical Technology Co., LtdPRB-CR-S2026-09-29
06974813832810NASinovation (Beijing) Medical Technology Co., LtdTT-50-45D2026-09-29
06974813832827NASinovation (Beijing) Medical Technology Co., LtdGD-122026-09-29
06974813832834NASinovation (Beijing) Medical Technology Co., LtdSDA-A21-32026-09-29
06974813832841NASinovation (Beijing) Medical Technology Co., LtdSDA-A30-12026-09-29
00850088866001CBYONMED-SURGICAL SERVICES, INC.900002026-09-25
06974813830069NASinovation (Beijing) Medical Technology Co., Ltd371000032023-08-31
06974813830076NASinovation (Beijing) Medical Technology Co., Ltd371000052023-08-31
06974813830083NASinovation (Beijing) Medical Technology Co., Ltd371000132023-08-31
06974813830113NASinovation (Beijing) Medical Technology Co., Ltd371000162023-08-31
06974813830199NASinovation (Beijing) Medical Technology Co., Ltd371000082023-08-31
06974813830205NASinovation (Beijing) Medical Technology Co., Ltd371000092023-08-31
07340201503683Leksell Vantage Stereotactic SystemElekta Solutions AB11364312026-08-18
07340201503713Leksell Vantage Stereotactic SystemElekta Solutions AB11365452026-08-18
07340201503720Leksell Vantage Stereotactic SystemElekta Solutions AB11365612026-08-18
07340201503744Leksell Vantage Stereotactic SystemElekta Solutions AB11365122026-08-18
07340201503768Leksell Vantage Stereotactic SystemElekta Solutions AB11365282026-08-18
07340201503942Leksell Vantage Stereotactic SystemElekta Solutions AB15780972026-08-18
07340201503959Leksell Vantage Stereotactic SystemElekta Solutions AB15780942026-08-18
00763000539108SteathStationMEDTRONIC NAVIGATION, INC.97364232022-02-07
00763000539177SteathStationMEDTRONIC NAVIGATION, INC.97364262022-02-07
00763000539238SteathStationMEDTRONIC NAVIGATION, INC.97364262023-08-04
04719878691024Nao Trac SBRAIN NAVI BIOTECHNOLOGY CO., LTD.FPNT02012026-07-25
03662724000611neuromate - Tool guideRENISHAW MAYFIELDOD15 - Microdrive AlphaOmega2026-07-14
03662724000642neuromate - Tool guideRENISHAW MAYFIELDOD15 - Microdrive FHC stardrive - ZD Leibinger2026-07-14
03662724000727neuromate - frame attachmentRENISHAW MAYFIELDIntegra CRW frame attachment - 15' angle2026-07-14
00650551006787PMT CORPORATION - STEREOTACTICPMT CORPORATION2103-15-402026-07-07
07340201502976Leksell Vantage Stereotactic SystemElekta Solutions AB11191152026-06-10
00650551006701PMT CORPORATION - STEREOTACTICPMT CORPORATION2103-15-20-NS2026-06-09
00650551006718PMT CORPORATION - STEREOTACTICPMT CORPORATION2103-15-25-NS2026-06-09
00650551006725PMT CORPORATION - STEREOTACTICPMT CORPORATION2103-15-30-NS2026-06-09
00650551006732PMT CORPORATION - STEREOTACTICPMT CORPORATION2103-15-35-NS2026-06-09
03664539003405NADIXI MEDICALWIRE GUIDE2022-01-01
07340201501887Leksell Vantage Stereotactic SystemElekta Solutions AB10400642025-03-31
00650551006558PMT CORPORATION - STEREOTACTICPMT CORPORATION2103-2572026-05-18
00763000457372Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359172021-04-10
00763000457396Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359172021-04-10
00763000457587Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359212021-04-10
00763000457600Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359212021-04-10
00763000457624Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359212021-04-10
00763000457631Medtronic NavigationMEDTRONIC NAVIGATION, INC.97359212021-04-10
00763000457730Medtronic NavigationMEDTRONIC NAVIGATION, INC.97362262021-04-10
00763000457747Medtronic NavigationMEDTRONIC NAVIGATION, INC.97362262021-04-10
00763000457754Medtronic NavigationMEDTRONIC NAVIGATION, INC.97362262021-04-10
00763000457761Medtronic NavigationMEDTRONIC NAVIGATION, INC.97362262021-04-10
00763000457778Medtronic NavigationMEDTRONIC NAVIGATION, INC.97362262021-04-10
00763000457785Medtronic NavigationMEDTRONIC NAVIGATION, INC.97363502021-04-10
00816589021240AtamA SystemMONTERIS MEDICAL INC206482022-12-14
00816589021257Mini-Bolt SystemMONTERIS MEDICAL INC207552022-12-14
00816589021264Mini-Bolt SystemMONTERIS MEDICAL INC208202022-12-14
00816589021271Mini-Bolt SystemMONTERIS MEDICAL INC208212022-12-14
00816589021288Mini-Bolt SystemMONTERIS MEDICAL INC210652022-12-14
00816589021295Mini-Bolt SystemMONTERIS MEDICAL INC208022022-12-14
00816589021301Mini-Bolt SystemMONTERIS MEDICAL INC211542022-12-14
00816589021318Mini-Bolt SystemMONTERIS MEDICAL INC211532022-12-14
00816589021325Mini-Bolt SystemMONTERIS MEDICAL INC206592022-12-14
00816589021332Mini-Bolt SystemMONTERIS MEDICAL INC206772022-12-14
00816589021349Mini-Bolt SystemMONTERIS MEDICAL INC206932022-12-14
00816589021356Mini-Bolt SystemMONTERIS MEDICAL INC207542022-12-14
00816589021363Mini-Bolt SystemMONTERIS MEDICAL INC206282022-12-14
00816589021370Mini-Bolt SystemMONTERIS MEDICAL INC206942022-12-14