FDA.reportPublic FDA data

NaviNetics Skull Anchor Extended Rescue Screw Kit

Primary DI
10850023620214
Brand
NaviNetics Skull Anchor Extended Rescue Screw Kit
Company
Navinetics, Inc.
Model
NN1600
Catalog number
NN1600
Published
2023-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
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
K231392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231392000NaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc.2023-07-14HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850023620214PrimaryGS10
10850023620238Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085002362021410850023620214
1085002362023810850023620238

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
838320260
Device count
20
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
10850023620122NaviNetics Skull Anchor Key Kit NN12102022-11-08
10850023620009NaviNetics Skull Anchor Rescue Screw KitNN14002022-11-08
10850023620016NaviNetics Reusable Stereotactic FrameNN11002022-11-08
10850023620023NaviNetics CT Localizer KitNN01202022-11-08
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
00763000811129MedtronicMEDTRONIC NAVIGATION, INC.HAW2026-06-07
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