FDA Registration
Active
🇺🇸 United States
Struxxure
Reg #: 3009504230
·
FEI: 3009504230
·
Expires 2025
Products
8
Proprietary Names
4
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Sterigenics Radiation Technologies IN, Inc
- Registration Number
- 3009504230
- FEI Number
- 3009504230
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4394 East Park 30 Drive
- City
- Columbia City
- State
- IN
- ZIP
- 46725
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141376
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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-07-08 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-07-08 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-07-08 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2025-07-08 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-07-08 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2025-07-08 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-07-08 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-07-08 |
Proprietary Names
Struxxure
Inertia
Facet Fixx
Honour
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)