FDA Registration
Active
🇺🇸 United States
Malibu Spinal System
Reg #: 3012120772
·
FEI: 3012120772
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- SEASPINE ORTHOPEDICS CORPORATION
- Registration Number
- 3012120772
- FEI Number
- 3012120772
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5770 Armada Dr
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K051942
Owner / Operator
- Firm Name
- SeaSpine Orthopedics Corporation
- Operator Number
- 10049589
- Address
- 5770 Armada Dr
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2015-06-28 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2015-06-28 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2015-06-28 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2015-06-28 |
Proprietary Names
Malibu Spinal System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device