FDA Registration
Active
🇮🇱 Israel
PATHKEEPER SURGICAL LTD.
Reg #: 3027153110
·
FEI: 3027153110
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PATHKEEPER SURGICAL LTD.
- Registration Number
- 3027153110
- FEI Number
- 3027153110
- Status
- Active
- Expiry Year
- 2026
- 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
- Path Keeper
- Contact Name
- Ryan LeBlanc
- Address
- 93 Shennecossett Rd
- City
- Groton
- State
- CT
- ZIP
- 06340
- 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 Surgical Navigation System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility