FDA Registration
Active
🇺🇸 United States
Zeta Cranial Navigation System (ZNS131-US)
Reg #: 3022310762
·
FEI: 3022310762
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ZETA SURGICAL INC.
- Registration Number
- 3022310762
- FEI Number
- 3022310762
- Status
- Active
- Expiry Year
- 2025
- 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
- 115 Kingston Street, Floor 2
- City
- Boston
- State
- MA
- Postal Code
- 02111
- Country
- US
- Correspondent
- Jose Amich
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-03-20 |
Proprietary Names
Zeta Cranial Navigation System (ZNS131-US)
Establishment Types
Manufacture Medical Device