FDA Registration
Active
🇺🇸 United States
Malibu Spinal System
Reg #: 3012120772
·
FEI: 3012120772
·
Expires 2025
Products
6
Proprietary Names
8
Establishment Types
2
Classifications
6
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
- K232566
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 | 2024-08-28 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2024-08-28 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-08-28 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2024-08-28 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-08-28 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-08-28 |
Proprietary Names
Malibu Spinal System
Daytona Small Stature Spinal System
Mariner Outrigger Revision System
Mariner RDX System
Mariner Deformity System
Mariner MIS Pedicle Screw System
Mariner Pedicle Screw System
NewPort Spinal System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device