FDA Registration
Active
🇺🇸 United States
Ortho1399 (SN,EP1) - ISS Integrated Spine System
Reg #: 1643817
·
FEI: 1643817
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC
- Registration Number
- 1643817
- FEI Number
- 1643817
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1435 ISOMEDIX PLACE
- City
- EL PASO
- State
- TX
- ZIP
- 79936
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061524
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 | 2012-12-19 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2012-12-19 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2012-12-19 |
Proprietary Names
Ortho1399 (SN,EP1) - ISS Integrated Spine System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)