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…
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).
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Zeta Stylet → S | Listed by | Zeta Surgical Inc., United States |
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K253663 |
| Record published | 2026-05-26 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Shipping box of 5 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.