FDA Registration
Active
🇮🇱 Israel
PathKeeper System
Reg #: 3027153110
·
FEI: 3027153110
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PATHKEEPER SURGICAL LTD.
- Registration Number
- 3027153110
- FEI Number
- 3027153110
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Hatachana 1, Migdal Menivim floor 1, Spaces
- City
- Kfar-Saba Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K222355
Owner / Operator
- Firm Name
- PathKeeper Surgical LTD.
- Operator Number
- 10087736
- Address
- Hatachana 1, Migdal Menivim floor 1, Spaces
- City
- Kfar-Saba
- State
- Central
- Postal Code
- 4453001
- Country
- IL
- Correspondent
- Erez Lampert
US Agent
- Business Name
- PathKeeper Inc.
- Contact Name
- Erez Lampert
- Address
- 1013 Centre Rd Ste 403B
- City
- Wilmington
- State
- DE
- ZIP
- 19805
- Country
- US
- [email protected]
- Phone
- 860 3346493
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-04-02 |
Proprietary Names
PathKeeper System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device