FDA Registration
Active
🇮🇱 Israel
XVision Spine System (XVS)
Reg #: 3016571711
·
FEI: 3016571711
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Augmedics Ltd.
- Registration Number
- 3016571711
- FEI Number
- 3016571711
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 Ha-Otsma St
- City
- Yokneam Illit Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K190929
Owner / Operator
- Firm Name
- Augmedics Inc.
- Operator Number
- 10062650
- Address
- 21 South Evergreen Street, Suite 230
- City
- Arlington Heights
- State
- IL
- Postal Code
- 60005
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2020-02-26 |
Proprietary Names
XVision Spine System (XVS)
Establishment Types
Manufacture Medical Device