FDA Registration
Active
🇺🇸 United States
ZETA SURGICAL INC.
Reg #: 3022310762
·
FEI: 3022310762
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ZETA SURGICAL INC.
- Registration Number
- 3022310762
- FEI Number
- 3022310762
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 280 Summer St Fl 7
- City
- Boston
- State
- MA
- ZIP
- 02210
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242351
Owner / Operator
- Firm Name
- Zeta Surgical Inc.
- Operator Number
- 10084934
- Address
- 280 Summer Street, Floor 7
- City
- Boston
- State
- MA
- Postal Code
- 02210
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-03-20 |
| Electromechanical Arm For A Transcranial Magnetic Stimulation System | QFF | Class 2 | Neurology | No | 2026-01-07 |
| Extracranial Positional System For A Transcranial Magnetic Stimulation System | SGE | Class 2 | Neurology | No | 2026-01-07 |
Proprietary Names
Zeta Cranial Navigation System (ZNS131-US)
Zeta TMS Navigation System
Zeta Stylet
Zeta Bolt
Establishment Types
Manufacture Medical Device