Data / Medical devices / United States / Zeta Surgical Inc.
Zeta Surgical Inc.: FDA-registered device maker in Boston, MA, United States, 3 510(k) clearances
Zeta Surgical Inc. is registered with the FDA (registration 3022310762) in Boston, MA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 1, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022310762
- Address
- 280 Summer St Fl 7, Boston, MA, United States, 02210
- Owner or operator
- Zeta Surgical Inc. (10084934)
- Roles
- Manufacturer
- First device listed
- March 20, 2025
- Registered through
- 2026
- Brand names listed
- Zeta Bolt, Zeta Cranial Navigation System (ZNS131-US), Zeta Stylet, Zeta TMS Navigation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electromechanical Arm For A Transcranial Magnetic Stimulation System | QFF | 2 | Manufacturer | accessdata.fda.gov |
| Extracranial Positional System For A Transcranial Magnetic Stimulation System | SGE | 2 | Manufacturer | accessdata.fda.gov |
| Neurological Stereotaxic Instrument | HAW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 1, 2026 | K253663 | Zeta Navigation System | HAW | Substantially Equivalent | Zeta Surgical, Inc. | accessdata.fda.gov |
| October 10, 2025 | K251927 | Zeta Navigation System (ZNS131-US) | SGE | Substantially Equivalent | Zeta Surgical, Inc. | accessdata.fda.gov |
| October 4, 2024 | K242351 | Zeta Cranial Navigation System (ZNS131-US) | HAW | Substantially Equivalent | Zeta Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electromechanical Arm For A Transcranial Magnetic Stimulation System
- All makers of Neurological Stereotaxic Instrument
Updated May 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.