FDA Registration
Active
🇺🇸 United States
Total Hip Prosthesis CLP Offset Total Hip System
Reg #: 1649518
·
FEI: 3001236277
·
Expires 2025
Products
8
Proprietary Names
3
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 1649518
- FEI Number
- 3001236277
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3125 Wichita Court
- City
- Fort Worth
- State
- TX
- ZIP
- 76140
- Country
- US
Regulatory Submissions
- 510(k) Number
- K052320
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, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2013-01-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-01-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2013-01-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2013-01-14 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2013-01-14 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2013-01-14 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2013-01-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2013-01-14 |
Proprietary Names
Total Hip Prosthesis CLP Offset Total Hip System
CLP® HIP SYSTEM
Total Hip Prosthesis CLP Revision
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)