FDA.reportPublic FDA data

ZETA SURGICAL INC.

Matched from indexed company URL: Zeta Surgical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30223107623022310762ZETA SURGICAL INC.1N2026-01-01280 Summer St Fl 7 Boston MA US 02210

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860012056804Zeta Stylet — S - The Zeta Stylet is a guiding stylet to be used in conjunction with the Zeta Navigation System for navigated placement of catheters, shunts or similar devices during cranial procedures. The instrument is single-use and not intended for reprocessing or reuse. The stylet is designed with mounting posts to attach the NDI passive marker spheres (K033621) for stereotaxic navigation. These mounting posts are pre-assembled on the Stylet handle during assembly. The Stylet with attached mounting posts is provided clean and non-sterile to the clients (e.g., hospitals). The clients are required to sterilize the Stylet according to the provided Instructions for Use (IFU) and store according before the procedure. The NDI passive marker spheres are provided sterile. The users are trained on installing the NDI passive marker spheres before the procedure. The Zeta Stylet is compatible with catheters with inner diameter from 1.5 mm to 1.9 mm. Both the handle and the rod of the Stylet are made of Titanium (grade 23). The mounting post is made of medical-grade stainless steel. The mounting posts and NDI passive marker spheres are supplied off-the-shelf by NDI (Canada).8572254138hieu.lemau@zetasurgical.com
00860012056804Zeta Stylet — S - The Zeta Stylet is a guiding stylet to be used in conjunction with the Zeta Navigation System for navigated placement of catheters, shunts or similar devices during cranial procedures. The instrument is single-use and not intended for reprocessing or reuse. The stylet is designed with mounting posts to attach the NDI passive marker spheres (K033621) for stereotaxic navigation. These mounting posts are pre-assembled on the Stylet handle during assembly. The Stylet with attached mounting posts is provided clean and non-sterile to the clients (e.g., hospitals). The clients are required to sterilize the Stylet according to the provided Instructions for Use (IFU) and store according before the procedure. The NDI passive marker spheres are provided sterile. The users are trained on installing the NDI passive marker spheres before the procedure. The Zeta Stylet is compatible with catheters with inner diameter from 1.5 mm to 1.9 mm. Both the handle and the rod of the Stylet are made of Titanium (grade 23). The mounting post is made of medical-grade stainless steel. The mounting posts and NDI passive marker spheres are supplied off-the-shelf by NDI (Canada).8572725703jose.amich@zetasurgical.com
00860012056811Zeta TMS Navigation System - The Zeta TMS Navigation System is a stereotaxic, image-guided planning and guidance system enabling computer-assisted procedures. The system assists the trained clinical professionals with accurate positioning of the coils of TMS treatment systems relative to patient anatomy by displaying the position of a navigated TMS coil relative to 3D neuroimaging scans. The system provides navigation in three planes (axial, sagittal, and coronal) and enables the selection of target anatomical points. The underlying RealTrack algorithm allows for real-time tracking of head movement using only the patient’s native anatomical features, eliminating the need for rigid head immobilization, body-mounted frames, or facial fiducials.8572254138hieu.lemau@zetasurgical.com
00860012056811Zeta TMS Navigation System - The Zeta TMS Navigation System is a stereotaxic, image-guided planning and guidance system enabling computer-assisted procedures. The system assists the trained clinical professionals with accurate positioning of the coils of TMS treatment systems relative to patient anatomy by displaying the position of a navigated TMS coil relative to 3D neuroimaging scans. The system provides navigation in three planes (axial, sagittal, and coronal) and enables the selection of target anatomical points. The underlying RealTrack algorithm allows for real-time tracking of head movement using only the patient’s native anatomical features, eliminating the need for rigid head immobilization, body-mounted frames, or facial fiducials.8572725703jose.amich@zetasurgical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3048581958810506K253663Zeta Navigation SystemHAW2026-05-01
3048581856214809K251927Zeta Navigation System (ZNS131-US)SGE2025-10-10
3048581843731956K242351Zeta Cranial Navigation System (ZNS131-US)HAW2024-10-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HAW22026-05-01
SGE12025-10-10

PMN#

GUDID#

Zeta TMS Navigation System - The Zeta TMS Navigation System is a stereotaxic, image-guided planning and guidance system enabling computer-assisted procedures. The system assists the trained clinical professionals with accurate positioning of the coils of TMS treatment systems relative to patient anatomy by displaying the position of a navigated TMS coil relative to 3D neuroimaging scans. The system provides navigation in three planes (axial, sagittal, and coronal) and enables the selection of target anatomical points. The underlying RealTrack algorithm allows for real-time tracking of head movement using only the patient’s native anatomical features, eliminating the need for rigid head immobilization, body-mounted frames, or facial fiducials.

Zeta Surgical Inc.

2026-05-26

Zeta Stylet — S - The Zeta Stylet is a guiding stylet to be used in conjunction with the Zeta Navigation System for navigated placement of catheters, shunts or similar devices during cranial procedures. The instrument is single-use and not intended for reprocessing or reuse. The stylet is designed with mounting posts to attach the NDI passive marker spheres (K033621) for stereotaxic navigation. These mounting posts are pre-assembled on the Stylet handle during assembly. The Stylet with attached mounting posts is provided clean and non-sterile to the clients (e.g., hospitals). The clients are required to sterilize the Stylet according to the provided Instructions for Use (IFU) and store according before the procedure. The NDI passive marker spheres are provided sterile. The users are trained on installing the NDI passive marker spheres before the procedure. The Zeta Stylet is compatible with catheters with inner diameter from 1.5 mm to 1.9 mm. Both the handle and the rod of the Stylet are made of Titanium (grade 23). The mounting post is made of medical-grade stainless steel. The mounting posts and NDI passive marker spheres are supplied off-the-shelf by NDI (Canada).

Zeta Surgical Inc.

2026-05-26