NaviNetics Standard Skull Anchor Screw

Primary DI
10850023620252
Brand
NaviNetics Standard Skull Anchor Screw
Company
Navinetics, Inc.
Model
NN1800
Catalog number
NN1800
Published
2023-11-10
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
10850023620252PrimaryGS10
10850023620269Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085002362025210850023620252
1085002362026910850023620269

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
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
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

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07613327499711N/AStryker Leibinger GmbH & Co. KGHAW2023-03-23
07613327500516N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500561N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
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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
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