FDA.reportPublic FDA data

NaviNetics CT Localizer Kit

Primary DI
10850023620023
Brand
NaviNetics CT Localizer Kit
Company
Navinetics, Inc.
Model
NN0120
Published
2022-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
K210700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210700000NaviNetics D1 Stereotactic SystemNavinetics, Inc.2021-06-17HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850023620023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085002362002310850023620023

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

Regulatory Flags#

DUNS number
838320260
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850023620252NaviNetics Standard Skull Anchor ScrewNN1800NN18002023-11-10
10850023620245NaviNetics Driver Handle NN01102023-11-10
10850023620269NaviNetics Standard Skull Anchor ScrewNN1800NN18002023-11-10
10850023620276NaviNetics Skull Anchor Key and Drill NN1215NN12152023-11-10
10850023620177NaviNetics Cannula and Stylet Kit (To Target) NN1250NN12502023-07-24
10850023620184NaviNetics Microdrive Adapter ANN0160NN01602023-07-24
10850023620191NaviNetics Microdrive Adapter FNN0170NN01702023-07-24
10850023620207NaviNetics Skull Anchor Extended Screw KitNN1700NN17002023-07-24
10850023620214NaviNetics Skull Anchor Extended Rescue Screw KitNN1600NN16002023-07-24
10850023620122NaviNetics Skull Anchor Key Kit NN12102022-11-08
10850023620009NaviNetics Skull Anchor Rescue Screw KitNN14002022-11-08
10850023620016NaviNetics Reusable Stereotactic FrameNN11002022-11-08
10850023620030NaviNetics MR Localizer KitNN01302022-11-08
10850023620047NaviNetics Key Placement Guide KitNN01102022-11-08
10850023620054NaviNetics Ground Truth Fixture NN13002022-11-08
10850023620078NaviNetics Reusable Stereotactic System NN10002022-11-08
10850023620061NaviNetics Skull Anchor Key Kit NN12102022-11-08
10850023620153NaviNetics Cannula and Stylet KitNN12302022-11-08
10850023620160NaviNetics MR Localizer Tubing KitNN12402022-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503829Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503836Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503843Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
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