FDA Registration
Active
🇺🇸 United States
Xenco6850 (NT) - SETx Pedicle Screw System
Reg #: 2032098
·
FEI: 3003058448
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Isomedix Operations, Inc
- Registration Number
- 2032098
- FEI Number
- 3003058448
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1000 Sarah Pl
- City
- ONTARIO
- State
- CA
- ZIP
- 91761
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151733
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 |
|---|---|---|---|---|---|
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-12-04 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-12-04 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-12-04 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-12-04 |
Proprietary Names
Xenco6850 (NT) - SETx Pedicle Screw System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)