Zeta Navigation System

Primary DI
00860012056828
Brand
Zeta Navigation System
Company
Zeta Surgical Inc.
Model
ZNS131-US
Device description
The Zeta Navigation System is a stereotactic, image-guided planning and intraoperative guidance system enabling computer-assisted cranial surgical procedures. The system assists surgeons in the precise positioning of surgical instruments relative to patient anatomy by displaying the position of navigated surgical instruments relative to 3D preoperative medical scans. A core feature of the Zeta Navigation System is that it can provide surgical navigation without the need for rigid head immobilization, body-mounted frames, or fiducials, instead using its underlying RealTrack algorithm for accurate, real-time tracking of head movement using only the patient’s native anatomical features. This enables the ZETA system to be deployed in less acute surgical settings such as interventional procedure suites, with minimal setup time or workflow interruption, and relying only on non-procedure-specific 3D imaging. The Zeta Navigation System consists of a single cart, a software user interface, and a set of compatible navigated instruments, sterile equipment covers, and surgical drapes.
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K242351000
K253663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242351000Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.2024-10-04HAW
K253663000Zeta Navigation SystemZeta Surgical, Inc.2026-05-01HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908008085468PreviousGS10
00860012056828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
08908008085468089080080854688908008085468
00860012056828008600120568288600120568280860012056828

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic neuronavigation/planning systemA mobile assembly of mains electricity (AC-powered) electronic and optical devices designed to receive and analyse patient magnetic resonance imaging (MRI) images and position landmarks manually or automatically on these images, then register the images by the mean of a three-dimensional (3-D) optical positioning system (frameless stereotactic neuronavigation) to provide real-time relative positioning for the treatment probes and instruments. It is typically used by healthcare providers in psychiatry, neuropsychiatry, and neurology for preoperative planning, in particular for consecutive image-guided transcranial magnetic stimulation (TMS) treatment sessions.

Contacts#

Phone, Email table
PhoneEmail
+1 857-225-4138hieu.lemau@zetasurgical.com
+1 (857) 272-5703jose.amich@zetasurgical.com

Regulatory Flags#

DUNS number
117227085
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00860012056804Zeta Stylet — SZSS-110 US2026-05-26
00860012056811Zeta TMS Navigation SystemZNS131-US2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10381780252436Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252443Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14