FDA.reportPublic FDA data

Leksell Vantage Stereotactic System

Primary DI
07340048306065
Brand
Leksell Vantage Stereotactic System
Company
Elekta Solutions AB
Model
1040026
Catalog number
1040027
Device description
FirmFix™ Ruler
Published
2024-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
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
K171123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171123000Leksell Vantage Stereotactic SystemElekta Instrument AB2017-09-15HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340201501368PrimaryGS10
07340048306065Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340201501368073402015013687340201501368
07340048306065073400483060657340048306065

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
353272181
Device count
200
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
true
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
07340201501887Leksell Vantage Stereotactic System10400642025-03-31
07340201503737VISUAL GUIDANCE157397215739722026-04-28
07340201500118MonacoMonaco 6.32026-03-20
07340201503461EMLA (Elekta EVO)15716442026-02-16
07340201503898Leksell GammaPlan15777562026-02-04
07340201502136Leksell GammaPlan15677142024-02-14
07340201503782AQUAAQUA 3.32025-12-10
07340201501368Leksell Vantage Stereotactic System104002610400272024-06-18
07340201501795Leksell Vantage Stereotactic System104011010401102024-06-17
07340201501535Leksell Vantage Stereotactic System104004510400452024-06-17
07340201502433Leksell Stereotactic System10403222025-10-17
07340201502266Leksell Stereotactic System104036010403152025-09-17
07340201502426Leksell Stereotactic System104049010403232025-09-17
07340201502457Leksell Stereotactic System10404991040319 2025-09-17
07340201502471Leksell Stereotactic System104035610403132025-09-17
07340201502495Leksell Stereotactic System104036410403172025-09-17
07340201502587Leksell Stereotactic System104035810403142025-09-17
07340201502273Leksell Stereotactic System104036010403152025-09-17
07340201503317Leksell Stereotactic System104049010403232025-09-17
07340201502440Leksell Stereotactic System104032110403212025-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012056828Zeta Navigation SystemZeta Surgical Inc.HAW2026-06-02
08720892330826Ball Joint Guide Array (BJGA)-Navigation SetBayer Medical Care B.V.HAW2026-04-24
08720892330833Ball Joint Guide Array (BJGA)-Guide SetBayer Medical Care B.V.HAW2026-04-24
07340201501887Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2025-03-31
10381780542278CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
10381780542285CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
10381780542292Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-03
G076A012354A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
G076A012355A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
07613327499711N/AStryker Leibinger GmbH & Co. KGHAW2023-03-23
07613327500516N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500561N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500578N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327503265N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
10603295522850VELYSDEPUY (IRELAND)HAW2021-07-30
07613327413076n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413090n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413205n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
10603295493624SIGMADEPUY ORTHOPAEDICS, INC.HAW2018-04-19
10650551098277PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2018-01-28
10381780167334CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252252CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252351Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252368Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252375CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252382Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252399Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252405CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252412CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252429CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14