FDA Registration
Active
🇹🇭 Thailand
G SURGICAL CO., LTD.
Reg #: 3006378738
·
FEI: 3006378738
·
Expires 2026
Products
10
Proprietary Names
11
Establishment Types
4
Classifications
10
Registration Details
- Registration Name
- G SURGICAL CO., LTD.
- Registration Number
- 3006378738
- FEI Number
- 3006378738
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 294/62 Nalin Avenue, Ramkamhaeng Road, SAPANSUNG
- City
- BANGKOK Krung Thep Maha Nakhon
- Country
- TH
Regulatory Submissions
- 510(k) Number
- K103070
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
- Correspondent
- DONALD - GRAFTON
US Agent
- Business Name
- G Surgical LLC
- Contact Name
- Donald Grafton
- Address
- 9433 Bee Cave Rd Bldg 3 Ste 101-A
- City
- Austin
- State
- TX
- ZIP
- 78733
- Country
- US
- [email protected]
- Phone
- 512 4944749
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2011-04-11 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-12-20 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2016-09-13 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2015-12-28 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2015-12-28 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2007-01-09 |
| 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 Interlaminal | KWP | Class 2 | Orthopedic | No | 2017-12-20 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2017-12-20 |
Proprietary Names
GPS¿ Anterior Cervical Plate System
G Surgical Marksman MIS System
surgical instrument tray-GPS pedicle screw system
G Surgical Marksman System
GPS Spacers
NON POWERED
HAND INSTRUMENT
G Surgical OCT Spinal System
GPS, G Surgical Pedicle System
GPS Cervical Spacers
G Surgical Marksman Spinal Deformity System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device