FDA Registration
Active
🇺🇸 United States
MR Conditional
Reg #: 3015399803
·
FEI: 3015399803
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Jabil Inc. (Monument)
- Registration Number
- 3015399803
- FEI Number
- 3015399803
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1051 Synthes Avenue
- City
- Monument
- State
- CO
- ZIP
- 80132
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160553
Owner / Operator
- Firm Name
- Jabil Inc.
- Operator Number
- 9074019
- Address
- 10800 Roosevelt Blvd.
- City
- Saint Petersburg
- State
- FL
- Postal Code
- 33716
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2024-08-01 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-08-01 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2024-08-01 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2024-08-01 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2024-08-01 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2024-08-01 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2024-08-01 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2024-08-01 |
Proprietary Names
MR Conditional
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)