FDA Registration
Active
🇺🇸 United States
Mariner Deformity System
Reg #: 3012120772
·
FEI: 3012120772
·
Expires 2025
Products
1
Proprietary Names
24
Establishment Types
2
Classifications
1
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
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 |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-06-28 |
Proprietary Names
Mariner Deformity System
Meridian Interbody System
Shoreline ACS Interbody System
Regatta Lateral System
SeaSpine
RAPID Graft Delivery
Anterior Disc Prep System
Lattus
NorthStar Facet Prep Instruments
IsoTis Cervical Facet Prep Instruments
Reef L Interbody System
NewPort Spinal System
Reef TO/TA System
Daytona Small Stature Spinal System
Manta Ray TDF Spacer
NorthStar OCT System
Malibu Spinal System
Mariner RDX System
Fathom Pedicle-Based Retractor
Mariner MIS Pedicle Screw System
Explorer TO System
Mariner Pedicle Screw System
Posterior Disc Prep System
Admiral ACP System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device