FDA Registration
Active
🇰🇷 South Korea
AnyPlus Spinal Fixation System
Reg #: 3005596514
·
FEI: 3005596514
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- GS MEDICAL CO., LTD.
- Registration Number
- 3005596514
- FEI Number
- 3005596514
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 90, Osongsaengmyeong 4-ro, Osong-eup,
- City
- Heungdeok-gu, Cheongju-si Chungbuk
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K091717
Owner / Operator
- Firm Name
- GS Solutions, Inc.
- Operator Number
- 9080979
- Address
- 3210 S. Susan St. Santa Ana 92704
- City
- Santa Ana
- State
- CA
- Postal Code
- 92704
- Country
- US
US Agent
- Business Name
- GS SOLUTIONS, INC.
- Contact Name
- James Shin
- Address
- 3210 S Susan St
- City
- Santa Ana
- State
- CA
- ZIP
- 92704
- Country
- US
- [email protected]
- Phone
- 949 3806385 ext. 163
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2010-01-26 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2010-01-26 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2010-01-26 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2010-01-26 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2010-01-26 |
Proprietary Names
AnyPlus Spinal Fixation System
Establishment Types
Manufacture Medical Device