FDA Registration
Active
🇺🇸 United States
Trauma Internal Fixation System
Reg #: 2183946
·
FEI: 1000116116
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- RMS CO.
- Registration Number
- 2183946
- FEI Number
- 1000116116
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8600 EVERGREEN BLVD.
- City
- MINNEAPOLIS
- State
- MN
- ZIP
- 55433
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111663
Owner / Operator
- Firm Name
- THE CRETEX COMPANIES, INC.
- Operator Number
- 9001389
- Address
- 311 LOWELL AVE., --
- City
- Elk River
- State
- MN
- Postal Code
- 55330
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2017-06-07 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2017-06-07 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2017-06-07 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2017-06-07 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2017-06-07 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2017-06-07 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2017-06-07 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2017-06-07 |
Proprietary Names
Trauma Internal Fixation System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)