FDA.reportPublic FDA data

StealthStation S8 Platform

Primary DI
00763000401191
Brand
StealthStation S8 Platform
Company
MEDTRONIC NAVIGATION, INC.
Model
9735670R
Device description
S8 CAMERA SYSTEM REFURB 9735670R
Published
2023-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological stereotaxic Instrument
OLOOrthopedic stereotaxic instrument
PGWEar, Nose, and Throat Stereotaxic Instrument

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162309000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162309000StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc.2017-03-31HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000401191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000401191007630004011917630004011910763000401191

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.

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00763000989965Stealth AXiS™ GEHC craniotomy Transducer Verification Device97365182026-08-15
00763000995195Stealth AXiS97366722026-08-14
00763000995218Stealth AXiS97366702026-08-14
00763000995232Stealth AXiS97366712026-08-14
00763000995256Stealth AXiS97366752026-08-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974813830083NASinovation (Beijing) Medical Technology Co., LtdHAW2023-08-31
06974813830113NASinovation (Beijing) Medical Technology Co., LtdHAW2023-08-31
06974813830199NASinovation (Beijing) Medical Technology Co., LtdHAW2023-08-31
06974813830205NASinovation (Beijing) Medical Technology Co., LtdHAW2023-08-31
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