FDA.reportPublic FDA data

Multi-purpose stereotactic surgery system

Definition
An electrically-powered 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 a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.
GUDID devices
271
Last updated
2026-10-06 03:50:27

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00199150071968Stealth AXiS Leica KitMEDTRONIC NAVIGATION, INC.97367562026-09-25
00199150071975Stealth AXiS Kinevo 900 KitMEDTRONIC NAVIGATION, INC.97367572026-09-25
00199150071982Stealth AXiS Pentero 900 KitMEDTRONIC NAVIGATION, INC.97367582026-09-25
00199150054404ZEISS TIVATO 700MEDTRONIC NAVIGATION, INC.97367222026-09-21
00199150054442ZEISS PENTERO 800SMEDTRONIC NAVIGATION, INC.97367242026-09-21
04260759931314Flexarm UniversalFiagon GmbHE0119732026-09-20
00199150067633Stealth AXiS Advanced Spine Referencing KitMEDTRONIC NAVIGATION, INC.97366922026-09-06
00763000994501Stealth AXiS Spine Referencing Kit SSMEDTRONIC NAVIGATION, INC.97366962026-09-06
00763000994525Stealth AXiS Advanced Spine Referencing Kit SSMEDTRONIC NAVIGATION, INC.97366972026-09-06
00763000994549Stealth AXiS EM Emitter Arm Bed Kit SSMEDTRONIC NAVIGATION, INC.97366982026-09-06
00763000994563Stealth AXiS EM Spine Retractors Kit SSMEDTRONIC NAVIGATION, INC.97366992026-09-06
00763000384234N/AMEDTRONIC NAVIGATION, INC.97361462021-08-13
00199150071593Stealth AXiS™ 3D-to-Fluoro Round Adapter KitMEDTRONIC NAVIGATION, INC.97367642026-08-22
00199150071616Stealth AXiS™ 3D-to-Fluoro Flat Adapter KitMEDTRONIC NAVIGATION, INC.97367662026-08-22
00763000989972Stealth AXiS™ 3D-to-Fluoro Flat C-arm TrackerMEDTRONIC NAVIGATION, INC.97365192026-08-22
00763000989989Stealth AXiS™ 3D-to-Fluoro Round C-arm TrackerMEDTRONIC NAVIGATION, INC.97365332026-08-22
00763000994587Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT Stainless SteelMEDTRONIC NAVIGATION, INC.97367002026-08-17
00193982621940DURAPROGLOBUS MEDICAL, INC.6262.2124S2026-08-14
00193982622039DURAPROGLOBUS MEDICAL, INC.6262.2142S2026-08-14
00193982622091DURAPROGLOBUS MEDICAL, INC.6262.3132S2026-08-14
00193982622114DURAPROGLOBUS MEDICAL, INC.6262.3134S2026-08-14
00193982622138DURAPROGLOBUS MEDICAL, INC.6262.4263S2026-08-14
00199150067664Stealth AXiS™ GEHC CRANIAL INTEGRATION KITMEDTRONIC NAVIGATION, INC.97366952026-08-15
00763000989958Stealth AXiS™ GEHC Craniotomy Transducer TrackerMEDTRONIC NAVIGATION, INC.97365172026-08-15
00763000989965Stealth AXiS™ GEHC craniotomy Transducer Verification DeviceMEDTRONIC NAVIGATION, INC.97365182026-08-15
00763000995195Stealth AXiSMEDTRONIC NAVIGATION, INC.97366722026-08-14
00763000995218Stealth AXiSMEDTRONIC NAVIGATION, INC.97366702026-08-14
00763000995232Stealth AXiSMEDTRONIC NAVIGATION, INC.97366712026-08-14
00763000995256Stealth AXiSMEDTRONIC NAVIGATION, INC.97366752026-08-14
00763000995270Stealth AXiSMEDTRONIC NAVIGATION, INC.97366762026-08-14
00763000995294Stealth AXiSMEDTRONIC NAVIGATION, INC.97366662026-08-14
00763000995317Stealth AXiSMEDTRONIC NAVIGATION, INC.97366672026-08-14
00763000995331Stealth AXiSMEDTRONIC NAVIGATION, INC.97366732026-08-14
00763000995355Stealth AXiSMEDTRONIC NAVIGATION, INC.97366682026-08-14
00763000995386Stealth AXiSMEDTRONIC NAVIGATION, INC.97366692026-08-14
00763000995416Stealth AXiSMEDTRONIC NAVIGATION, INC.97366642026-08-14
00763000995430Stealth AXiSMEDTRONIC NAVIGATION, INC.97366652026-08-14
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.97357622026-08-07
00199150054466N/AMEDTRONIC NAVIGATION, INC.97367262026-08-08
00199150057078AXIS AP ROBOTIC TOOL CHANGER 9736681MEDTRONIC NAVIGATION, INC.97366812026-08-09
00199150067626KIT 9736691 SPINE REFERENCINGMEDTRONIC NAVIGATION, INC.97366912026-08-07
00199150074396CLAMP 9736433 SPINE STRAIGHT TALLMEDTRONIC NAVIGATION, INC.97364332026-08-07
00199150074402CLAMP 9736465 SPINE STRAIGHT MEDIUMMEDTRONIC NAVIGATION, INC.97364652026-08-07
00199150074419CLAMP 9736434 SPINE STRAIGHT SHORTMEDTRONIC NAVIGATION, INC.97364342026-08-07
00199150074426CLAMP 9736467 SPINE DOUBLE MEDIUMMEDTRONIC NAVIGATION, INC.97364672026-08-07
00763000381141N/AMEDTRONIC NAVIGATION, INC.97314602026-08-08
00763000989927AXIS HYBRID REF FRAME 9736511MEDTRONIC NAVIGATION, INC.97365112026-08-07
00763000989941AXIS EM SEGMENT TRACKER DRIVER 9736513MEDTRONIC NAVIGATION, INC.97365132026-08-07
17290113780979XVS MARKERS WITH XLINK KITAUGMEDICS LTDASP000472021-08-05
07290113781696X2 HeadsetAUGMEDICS LTDX20010012025-11-19
00763000914097Stealth AXiSMEDTRONIC NAVIGATION, INC.97365032026-07-24
00763000914035Stealth AXiSMEDTRONIC NAVIGATION, INC.97364812026-07-17
00763000914042Stealth AXiSMEDTRONIC NAVIGATION, INC.97364822026-07-17
00763000914059Stealth AXiSMEDTRONIC NAVIGATION, INC.97364832026-07-17
00763000914066Stealth AXiSMEDTRONIC NAVIGATION, INC.97364842026-07-17
00763000914073Stealth AXiSMEDTRONIC NAVIGATION, INC.97364852026-07-17
00763000914080Stealth AXiSMEDTRONIC NAVIGATION, INC.97364862026-07-17
00763000953805Stealth AXiSMEDTRONIC NAVIGATION, INC.97365502026-07-17
00199150006427Stealth AXiSMEDTRONIC NAVIGATION, INC.97365512026-04-24
00199150056972N/AMEDTRONIC NAVIGATION, INC.97367442026-04-05
00199150056989N/AMEDTRONIC NAVIGATION, INC.97367452026-04-05
00199150056996N/AMEDTRONIC NAVIGATION, INC.97367462026-04-05
00199150071586Stealth AXiSMEDTRONIC NAVIGATION, INC.97367642026-04-19
00199150071609Stealth AXiSMEDTRONIC NAVIGATION, INC.97367662026-04-19
00763000401184MedtronicMEDTRONIC NAVIGATION, INC.9735669R2024-12-16
00763000882631MedtronicMEDTRONIC NAVIGATION, INC.97345902025-01-17
00763000882679MedtronicMEDTRONIC NAVIGATION, INC.97346822025-01-17
00763000882686MedtronicMEDTRONIC NAVIGATION, INC.97346832025-01-17
00763000882792MedtronicMEDTRONIC NAVIGATION, INC.97347342025-01-17
00763000882853MedtronicMEDTRONIC NAVIGATION, INC.97352492025-01-17
00763000882860MedtronicMEDTRONIC NAVIGATION, INC.97360602025-01-17
00763000882877MedtronicMEDTRONIC NAVIGATION, INC.97360612025-01-17
00763000928865Stealth AXiSMEDTRONIC NAVIGATION, INC.97365122026-04-04
00763000928872Stealth AXiSMEDTRONIC NAVIGATION, INC.97365112026-04-04
00763000928889Stealth AXiSMEDTRONIC NAVIGATION, INC.97365132026-04-04
00763000928896Stealth AXiSMEDTRONIC NAVIGATION, INC.97365172026-04-11
00763000928902Stealth AXiSMEDTRONIC NAVIGATION, INC.97365182026-04-11
00763000928919Stealth AXiSMEDTRONIC NAVIGATION, INC.97365212026-04-10
00763000928926Stealth AXiSMEDTRONIC NAVIGATION, INC.97365332026-04-10
00763000928933Stealth AXiSMEDTRONIC NAVIGATION, INC.97365102026-04-04