FDA Registration
Active
🇺🇸 United States
NexxtSpine14118 (CH2) - NEXXT MATRIXX®; TrellOss-A SA
Reg #: 3013820501
·
FEI: 3013820501
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Isomedix Operations Inc.
- Registration Number
- 3013820501
- FEI Number
- 3013820501
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 Nucifora Blvd
- City
- Chester
- State
- NY
- ZIP
- 10918
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202230
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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2024-08-19 |
Proprietary Names
NexxtSpine14118 (CH2) - NEXXT MATRIXX®; TrellOss-A SA
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)