FDA Registration
Active
🇺🇸 United States
F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System
Reg #: 3008583793
·
FEI: 3008583793
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
3
Classifications
4
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
- K231743
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 |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-01-03 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-01-03 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-01-03 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-01-03 |
Proprietary Names
F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198