Zeta Stylet — S

Primary DI
00860012056804
Brand
Zeta Stylet — S
Company
Zeta Surgical Inc.
Model
ZSS-110 US
Device description
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).
Published
2026-05-26
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
true

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
K253663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253663000Zeta Navigation SystemZeta Surgical, Inc.2026-05-01HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860012056808PackageGS15In Commercial Distribution
00860012056804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086001205680820860012056808
00860012056804008600120568048600120568040860012056804

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic surgery system probe, single-useA slender, rod-like, hand-held manual surgical instrument intended for use during image-guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8572254138hieu.lemau@zetasurgical.com
8572725703jose.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
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012056828Zeta Navigation SystemZNS131-US2026-06-02
00860012056811Zeta TMS Navigation SystemZNS131-US2026-05-26

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