FDA Registration
Active
🇺🇸 United States
GUARDIAN MEDICAL USA, INC
Reg #: 3016261131
·
FEI: 3016261131
·
Expires 2026
Products
12
Proprietary Names
2
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- GUARDIAN MEDICAL USA, INC
- Registration Number
- 3016261131
- FEI Number
- 3016261131
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11360 S Airfield Rd
- City
- Swanton
- State
- OH
- ZIP
- 43558
- Country
- US
Owner / Operator
- Firm Name
- Guardian Medical USA, LLC
- Operator Number
- 10062293
- Address
- 11360 S Airfield Rd
- City
- Swanton
- State
- OH
- Postal Code
- 43558
- Country
- US
- Correspondent
- Tracy Momany
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2026-05-29 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-12-30 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-12-30 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2020-01-09 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2020-01-09 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2020-01-09 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-10-04 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2024-06-27 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2026-06-02 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-06-02 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2020-12-30 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2020-12-30 |
Proprietary Names
CoLink Plating System
Precice Screws
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)