FDA Registration
Active
🇺🇸 United States
Xenco Medical Cervical Interbody System
Reg #: 3011181154
·
FEI: 3011181154
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- XENCO MEDICAL LLC
- Registration Number
- 3011181154
- FEI Number
- 3011181154
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9930 Mesa Rim Road
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140786
Owner / Operator
- Firm Name
- Xenco Medical, LLC
- Operator Number
- 10047563
- Address
- 9930 Mesa Rim Road
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Jason Haider
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2014-10-06 |
Proprietary Names
Xenco Medical Cervical Interbody System
Argus Cervical Interbody System
SETx Cervical Interbody System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility