FDA Registration
Active
🇺🇸 United States
Isomedix Operations Inc.
Reg #: 2032112
·
FEI: 3003076831
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Isomedix Operations Inc.
- Registration Number
- 2032112
- FEI Number
- 3003076831
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7685 ST.ANDREWS AVE.
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92154
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061579
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 9072619
- Address
- 5960 Heisley Road, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2023-07-12 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-07-12 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2023-07-12 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-07-12 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2023-07-12 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-07-12 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)