FDA Registration
Active
🇺🇸 United States
SPINEOLOGY INC.
Reg #: 2135156
·
FEI: 3003179719
·
Expires 2026
Products
15
Proprietary Names
27
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- SPINEOLOGY INC.
- Registration Number
- 2135156
- FEI Number
- 3003179719
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7800 THIRD STREET N., SUITE 600
- City
- Saint Paul
- State
- MN
- ZIP
- 55128
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181792
Owner / Operator
- Firm Name
- Spineology Inc
- Operator Number
- 9036813
- Address
- 7800 Third ST. N., Suite 600
- City
- Saint Paul
- State
- MN
- Postal Code
- 55128
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2018-11-19 |
| Intervertebral Body Graft Containment Device | OQB | Class 2 | Orthopedic | No | 2021-03-16 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2019-10-07 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2014-06-26 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-06-26 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-06-26 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2013-11-21 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2009-11-11 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2018-11-19 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2019-10-07 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-11-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2001-03-16 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2007-11-01 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2014-12-19 |
| Catheter, Balloon Type | GBA | Class 1 | General, Plastic Surgery | No | 2009-10-20 |
Proprietary Names
Duo Lumbar Interbody Fusion Device
OptiMesh Expandable Interbody Fusion System
Rampart One Lumbar Interbody Fusion System
Duo Ti Expandable Interbody Fusion System
Rampart O Lumbar Interbody Fusion Device
Fortress Pedicular Fixation System
ConneX Connectors
Threshold V2 Pedicular Fixation System
OptiMesh Multiplanar Expandable Interbody Fusion System
Surgical Instruments
Rampart One Lumbar Interbody Fusion Device
Capture Facet Fixation System
Spineology Navigation Instruments
Elite Expandable Interbody Fusion System
OptiMesh HA Nano Multiplanar Expandable Interbody Fusion System
Powered Brushes
SOAR Retractor System
Medius Midline Retractor System
Merlon Retractor System
Threshold Pedicular Fixation System
Palisade Pedicular Fixation System
Dual Chamber Expandable Interbody Fusion System
Duo Lumbar Interbody Fusion System
OptiMesh
OptiMesh Navigation Instruments
VIA Spinous Process Fixation System
Verify
Establishment Types
Manufacture Medical Device