FDA.reportPublic FDA data

Leksell Stereotactic System

Primary DI
07340048304542
Brand
Leksell Stereotactic System
Company
Elekta Instrument AB
Model
917119
Device description
LEFT INDICATOR PLATE SET
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
K152558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152558000Leksell Stereotactic System, Injection/ Aspiration Needle KitElekta Instrument AB2016-03-02HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340048304504Direct MarkingGS10
07340048304542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340048304504073400483045047340048304504
07340048304542073400483045427340048304542

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn 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.

Contacts#

Phone, Email table
PhoneEmail
+1(855)693-5358info.america@elekta.com

Regulatory Flags#

DUNS number
507772663
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07340048304474Leksell Stereotactic System9128772016-10-21
07340048304535Leksell Stereotactic System9171202016-09-24
07340048304559Leksell Stereotactic System9171182016-09-24
07340048311175Leksell Stereotactic System153003615300362017-02-07
07340048311182Leksell Stereotactic System153003815300382017-02-07
07340048311199Leksell Stereotactic System153003915300392017-02-07
07340048311205Leksell Stereotactic System153004015300402017-02-07
07340048311212Leksell Stereotactic System153004115300412017-02-07
07340048311403Leksell Stereotactic System100647210064722018-09-21
07340048311793Leksell Stereotactic System Neurosurgical Instruments10756472021-05-31
07340048300087Leksell Stereotactic System10038382016-09-24
07340048300094Leksell Stereotactic System10003492016-09-24
07340048300100Leksell Stereotactic SystemA1200-042016-09-24
07340048300124Leksell Stereotactic System9079992016-09-23
07340048300131Leksell Stereotactic System8111052016-09-23
07340048300148Leksell Stereotactic System10065812016-09-23
07340048300155Leksell Stereotactic System10065842016-09-23
07340048300162Leksell Stereotactic SystemA0227-042016-09-30
07340048300209Leksell Stereotactic System10008102016-09-23
07340048300216Leksell Stereotactic System100035110003512016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503683Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503713Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503720Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503744Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503768Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503942Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503959Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
00763000994587Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT Stainless SteelMEDTRONIC NAVIGATION, INC.HAW2026-08-17
00199150067664Stealth AXiS™ GEHC CRANIAL INTEGRATION KITMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00763000989958Stealth AXiS™ GEHC Craniotomy Transducer TrackerMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00763000989965Stealth AXiS™ GEHC craniotomy Transducer Verification DeviceMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00199150054466N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00763000381141N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.HAW2026-08-07
G076A900687A0Localite TMS Navigator TSLOCALITE GmbHHAW2026-08-03
04719878691024Nao Trac SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691208Foot ControllerBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693127Tag Support ArmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878694001Instrument Registration Platform CoverBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695022Instrument Holder SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695046Instrument Adaptor (3 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695060Instrument Adaptor (4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695084Instrument Adaptor (5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25