FDA Registration
Active
🇺🇸 United States
G Surgical LLC
Reg #: 3009169872
·
FEI: 3009169872
·
Expires 2026
Products
10
Proprietary Names
11
Establishment Types
4
Classifications
10
Registration Details
- Registration Name
- G Surgical LLC
- Registration Number
- 3009169872
- FEI Number
- 3009169872
- Status
- Active
- Expiry Year
- 2026
- 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
- K210890
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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2021-05-28 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2007-01-09 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2020-01-23 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2015-12-28 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2017-12-20 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2017-12-20 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-12-16 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-12-16 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2011-04-11 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2016-09-13 |
Proprietary Names
GPS Cervical Spacers
NON POWERED
HAND INSTRUMENT
G Surgical Marksman System
GPS Spacers
G Surgical OCT Spinal System
G Surgical Marksman MIS System
GPS, G Surgical Pedicle System
GPS¿ Anterior Cervical Plate System
G Surgical Marksman Spinal Deformity System
surgical instrument tray-GPS pedicle screw system
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility