FDA Registration
Active
🇺🇸 United States
PISCES-SA ALIF Interbody
Reg #: 3010531060
·
FEI: 3010531060
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- OSSEUS FUSION SYSTEMS LLC
- Registration Number
- 3010531060
- FEI Number
- 3010531060
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1931 Greenville Avenue, Suite 200
- City
- Dallas
- State
- TX
- ZIP
- 75206
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213935
Owner / Operator
- Firm Name
- OSSEUS FUSION SYSTEMS LLC
- Operator Number
- 10045353
- Address
- 1931 Greenville Avenue, suite 200
- City
- Dallas
- State
- TX
- Postal Code
- 75206
- 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 | 2022-05-10 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2022-05-10 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-05-10 |
Proprietary Names
PISCES-SA ALIF Interbody
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility