FDA.reportPublic FDA data

Stealth AXiS™ GEHC craniotomy Transducer Verification Device

Primary DI
00763000989965
Brand
Stealth AXiS™ GEHC craniotomy Transducer Verification Device
Company
MEDTRONIC NAVIGATION, INC.
Model
9736518
Device description
AXIS GEHC CRANI TRNSDCR VER DEV 9736518
Published
2026-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253379000Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.2026-03-26HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000989965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000989965007630009899657630009899650763000989965

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose stereotactic surgery systemAn 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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835233107
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150071968Stealth AXiS Leica Kit97367562026-09-25
00199150071975Stealth AXiS Kinevo 900 Kit97367572026-09-25
00199150071982Stealth AXiS Pentero 900 Kit97367582026-09-25
00199150054404ZEISS TIVATO 70097367222026-09-21
00199150054442ZEISS PENTERO 800S97367242026-09-21
00199150067633Stealth AXiS Advanced Spine Referencing Kit97366922026-09-06
00763000994501Stealth AXiS Spine Referencing Kit SS97366962026-09-06
00763000994525Stealth AXiS Advanced Spine Referencing Kit SS97366972026-09-06
00763000994549Stealth AXiS EM Emitter Arm Bed Kit SS97366982026-09-06
00763000994563Stealth AXiS EM Spine Retractors Kit SS97366992026-09-06
00763000384234N/A97361462021-08-13
00199150071593Stealth AXiS™ 3D-to-Fluoro Round Adapter Kit97367642026-08-22
00199150071616Stealth AXiS™ 3D-to-Fluoro Flat Adapter Kit97367662026-08-22
00763000989972Stealth AXiS™ 3D-to-Fluoro Flat C-arm Tracker97365192026-08-22
00763000989989Stealth AXiS™ 3D-to-Fluoro Round C-arm Tracker97365332026-08-22
00763000994587Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT Stainless Steel97367002026-08-17
00199150067664Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT97366952026-08-15
00763000989958Stealth AXiS™ GEHC Craniotomy Transducer Tracker97365172026-08-15
00763000995195Stealth AXiS97366722026-08-14
00763000995218Stealth AXiS97366702026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503829Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503836Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503843Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
00889024714113PLANNING STATION - USAMEDTECHHAW2026-09-28
00889024704213PLANNING STATION - USAMEDTECHHAW2026-02-23
04056481146702Curve NavigationBrainlab SEHAW2025-10-13
00889024679559ALLEN WRENCH 8MMMEDTECHHAW2025-07-15
00887868539978SEEG DRILL ADAPTOR 2.70MMMEDTECHHAW2025-06-24
00889024663282PLANNING STATION - ROSA ONE - USAMEDTECHHAW2024-02-20
00887868585951ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2023-10-30
03760244031129Trnsnsl Endscp Ovoid Ø6.18mm HolderMEDTECHHAW2023-10-27
04056481144500Curve Navigation 17700Brainlab SEHAW2023-05-22
03760244034793ROSA ONE SURGICAL ASSISTANT (US)MEDTECHHAW2022-06-20
03760244034922PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244035127PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244034625SEEG DRILL ADAPTOR Ø2.5MMMEDTECHHAW2022-02-18
03760244034632SEEG DRILL ADAPTOR Ø2.15MMMEDTECHHAW2022-02-18
03760244034649SEEG DRILL ADAPTOR Ø2.45MMMEDTECHHAW2022-02-18
03760244034656SEEG DRILL ADAPTOR Ø2.55MMMEDTECHHAW2022-02-18
03760244034663SEEG DRILL ADAPTOR Ø3.2MMMEDTECHHAW2022-02-18
03760244032195Optical distance sensorMEDTECHHAW2021-06-15
03760244034304ROBOT ROSA ONE (USA)MEDTECHHAW2021-05-31
03760244034403PLANNING STATION Rosa One -USAMEDTECHHAW2021-05-31
04056481143503Kick 2 Navigation StationBrainlab SEHAW2021-05-31
03760244030962CRW frame adaptorMEDTECHHAW2020-11-20
03760244031914LEKSELL FRAME REGISTRATION PLATESMEDTECHHAW2020-10-20