FDA Registration
Active
🇺🇸 United States
Humeral Short Stem System
Reg #: 1423662
·
FEI: 3000215273
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 1423662
- FEI Number
- 3000215273
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1003 Lakeside Drive
- City
- Gurnee
- State
- IL
- ZIP
- 60031
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173824
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2024-02-21 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2024-02-21 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2024-02-21 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2024-02-21 |
Proprietary Names
Humeral Short Stem System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)