FDA Registration
Active
🇺🇸 United States
Centerline
Reg #: 3007406875
·
FEI: 3007406875
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- GIZMO PRECISION MEDICAL LLC
- Registration Number
- 3007406875
- FEI Number
- 3007406875
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6N343 Mission Hills Drive
- City
- St Charles
- State
- IL
- ZIP
- 60175
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151196
Owner / Operator
- Firm Name
- Gizmo Precision Medical LLC
- Operator Number
- 10028400
- Address
- 6N343 Mission Hills Drive
- City
- St Charles
- State
- IL
- Postal Code
- 60175
- Country
- US
- Correspondent
- Angela Batker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2018-03-02 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2018-03-02 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2018-03-02 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2018-03-02 |
Proprietary Names
Centerline
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)