FDA.reportPublic FDA data

StealthStation Cranial Software

Primary DI
00763000368494
Brand
StealthStation Cranial Software
Company
MEDTRONIC NAVIGATION, INC.
Model
9735762
Device description
SFW 9735762 APP STEALTH S8 APPLICATION
Published
2020-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PGWEar, Nose, and Throat Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200723000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200723000StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)Medtronic Navigation, Inc.2020-06-26PGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000368494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000368494007630003684947630003684940763000368494

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
835233107
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150071999Medtronic40-405-12026-11-01
00824846012832Stealth97365512026-10-30
00763000995270Stealth AXiS97366762026-08-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780544197TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544210TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544234TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544258TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544272TruDi®ACCLARENT, INC.PGW2026-11-03
00824846012832StealthMEDTRONIC NAVIGATION, INC.PGW2026-10-30
00763000945817ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000945824ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000945831ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000945848ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000945855ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000957858ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
10381780544081TruDi®ACCLARENT, INC.PGW2026-10-15
04260759931314Flexarm UniversalFiagon GmbHPGW2026-09-20
04260759931697VirtuEye ProFiagon GmbHPGW2026-08-17
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2026-08-07
00199150006427Stealth AXiSMEDTRONIC NAVIGATION, INC.PGW2026-04-24
00763000738358AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738365AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738372AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738389AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738396AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
04056481146702Curve NavigationBrainlab SEPGW2025-10-13
04260759930003Integrated HeadrestFiagon GmbHPGW2025-06-25
04260759930133Navigation Unit Cube4DFiagon GmbHPGW2025-01-16
042607599301574K Navigation Unit Cube4DFiagon GmbHPGW2025-01-16
04260759930249Navigation SensorFiagon GmbHPGW2025-01-16
04260759930300FlexPointerFiagon GmbHPGW2025-01-16
04260759930317FlexPointer 1.5 mmFiagon GmbHPGW2025-01-16
04260759930324FlexTube 3mmFiagon GmbHPGW2025-01-16