FDA Registration
Active
🇺🇸 United States
Isomedix Operations, Inc.
Reg #: 1424263
·
FEI: 3003015552
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Isomedix Operations, Inc.
- Registration Number
- 1424263
- FEI Number
- 3003015552
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2500 Commerce Dr
- City
- Libertyville
- State
- IL
- ZIP
- 60048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140765
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-01-02 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-01-02 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-01-02 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-01-02 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-01-02 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-01-02 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)