FDA.reportPublic FDA data

AXiiiS Stereotactic Miniframe

Primary DI
00816589020182
Brand
AXiiiS Stereotactic Miniframe
Company
MONTERIS MEDICAL INC
Model
20503
Catalog number
AX-300-01
Device description
AXiiiS Trajectory Guide
Published
2016-09-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
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
K090240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090240000MONTERIS MEDICAL UFOMonteris Medical,2009-08-06HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816589020182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816589020182008165890201828165890201820816589020182

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(866)799-7655info@monteris.com

Regulatory Flags#

DUNS number
021415875
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816589021615Brasseler Twist Drillbit21332213322026-07-03
00816589021622Brasseler Twist Drillbit21345213452026-07-03
00816589021608Mini-Bolt Accessory Kit21180CMB000-AA2026-02-23
00816589021219Fiducial Marker, Sterile212512025-02-07
00816589021202Mini-Bolt System29008CMB016-AA-R2024-11-12
00816589021226Mini-Bolt System21247CMB-ST2024-08-08
00816589021196Mini-Bolt System21155CMBVUE-UP2024-05-20
00816589021585NeuroBlate NB3 FullFire™ 1.6 Laser Probe22002FFD-0162024-01-02
00816589021189Mini-Bolt System21228CMB-VX2024-03-21
00816589021158Mini-Bolt System21224CMB016-AA2023-12-20
00816589021561Mini-Bolt System21165CMB016-S2023-12-20
00816589021578Mini-Bolt System21209CMB016-UP2023-12-20
00816589021592Mini-Bolt System22004CMB016-MS2023-12-20
00816589021165Mini-Bolt System21237CMB022-VA2023-09-10
00816589021172Mini-Bolt System21239CMB033-VA2023-09-10
00816589021240AtamA System20648ASA0012022-12-14
00816589021257Mini-Bolt System20755CMB0222022-12-14
00816589021264Mini-Bolt System20820208202022-12-14
00816589021271Mini-Bolt System20821208212022-12-14
00816589021288Mini-Bolt System21065210652022-12-14

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