FDA Registration
Active
🇺🇸 United States
G Surgical Marksman MIS System
Reg #: 3009169872
·
FEI: 3009169872
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- G Surgical LLC
- Registration Number
- 3009169872
- FEI Number
- 3009169872
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9433 Bee Cave Road, Building 3, Suite 101-A
- City
- Austin
- State
- TX
- ZIP
- 78733
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240737
Owner / Operator
- Firm Name
- G SURGICAL LLC
- Operator Number
- 9096480
- Address
- 9433 Bee Cave Road, Building 3, Suite 101-A
- City
- Austin
- State
- TX
- Postal Code
- 78733
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-12-20 |
Proprietary Names
G Surgical Marksman MIS System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device