FDA Registration
Active
🇺🇸 United States
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Reg #: 3008583793
·
FEI: 3008583793
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- ZAVATION
- Registration Number
- 3008583793
- FEI Number
- 3008583793
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3670 Flowood Dr
- City
- Flowood
- State
- MS
- ZIP
- 39232
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230329
Owner / Operator
- Firm Name
- Zavation Medical Products LLC
- Operator Number
- 10055475
- Address
- 3670 Flowood Dr
- City
- Flowood
- State
- MS
- Postal Code
- 39232
- Country
- US
- Correspondent
- Elke Carter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2023-11-13 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2023-11-13 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2023-11-13 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2023-11-13 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2023-11-13 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-11-13 |
Proprietary Names
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198