FDA Registration
Active
🇺🇸 United States
WaveForm C Interbody System
Reg #: 3012120772
·
FEI: 3012120772
·
Expires 2025
Products
5
Proprietary Names
10
Establishment Types
1
Classifications
5
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
- K240830
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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2025-02-20 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2025-02-20 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-02-20 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-02-20 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-02-20 |
Proprietary Names
WaveForm C Interbody System
WaveForm TA Interbody System
Explorer TO System
Reef TO/TA System
Shoreline ACS and RT Interbody System
Regatta Lateral System
FORZA XP Expandable Spacer System
Meridian Interbody System
WaveForm A Interbody System
WaveForm TO Interbody System
Establishment Types
Manufacture Medical Device