FDA Registration
Active
🇺🇸 United States
AnyPlus Spinal Fixation System
Reg #: 3008850074
·
FEI: 3008850074
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- GS Solutions, Inc.
- Registration Number
- 3008850074
- FEI Number
- 3008850074
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3210 S Susan St
- City
- Santa Ana
- State
- CA
- ZIP
- 92704
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091717
Owner / Operator
- Firm Name
- GS Solutions, Inc.
- Operator Number
- 10035190
- Address
- 3210 S Susan St
- City
- Santa Ana
- State
- CA
- Postal Code
- 92704
- Country
- US
- Correspondent
- James (Hanjin) Shin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-07-14 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2016-07-14 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-07-14 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-07-14 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2016-07-14 |
Proprietary Names
AnyPlus Spinal Fixation System
Establishment Types
Repack or Relabel Medical Device