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Sign in to claim this brandSPINEOLOGY INC.
US
Last updated September 17, 2026
What SPINEOLOGY INC. makes
Spineology Inc. manufactures spinal fusion devices, including metallic and polymeric interbody fusion cages, non-bioabsorbable spinal bone screws, and internal spinal fixation systems with rods. Their portfolio also includes reusable surgical implant templates, retractors, and bone graft pouches for vertebral body applications. Devices like expandable interbody systems and pedicle fixation sets are designed for spinal stabilization procedures.
The company’s products are regulated under FDA’s Class I, Class II, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Spineology Inc. is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- 7800 THIRD STREET N., Saint Paul, MN, 55128
- Website
- spineology.com
- —
- —
- [email protected]
- Phone
- 651-256-8500
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003179719
- DUNS Number
- 033014361
Catalogue (1995)
Page 6 of 40| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SOAR Retractor System | 78-02-38-5 | FDA UDI | Class I | Active |
| Rampart O | 83-04-07-44 | FDA UDI | Class II | Active |
| Discectomy Set | 10-01-134 | FDA UDI | Class I | Active |
| OptiMesh Multiplanar Expandable Interbody Fusion System | 35-06-82 | FDA UDI | Class I | Active |
| Duo Ti Expandable Interbody Fusion System | 86-12-01-2 | FDA UDI | Class II | Active |
| Threshold V2 Pedicular Fixation System | 10-10-83-25 | FDA UDI | Class II | Active |
| Duo Ti Expandable Interbody Fusion System | 86-06-07 | FDA UDI | Class I | Active |
| OptiMesh Multiplanar Expandable Interbody Fusion System | 33-08-10 | FDA UDI | Class I | Active |
| Duo Ti Expandable Interbody Fusion System | 86-11-40-1 | FDA UDI | Class I | Active |
| Rampart O | 83-04-08 | FDA UDI | Class II | Active |
| Rampart One Lumbar Interbody Fusion System | 49-12-12 | FDA UDI | Class II | Active |
| Palisade Pedicular Fixation System | 67-05-01 | FDA UDI | Class I | Active |
| Medius Midline Retractor System | 66-02-01-12 | FDA UDI | Class I | Active |
| Rampart-O | 83-02-10-10 | FDA UDI | Class II | Active |
| Threshold Pedicle Screw | 10-10-09-5 | FDA UDI | Class II | Active |
| Threshold Pedicle Screw | 10-10-09-23 | FDA UDI | Class II | Active |
| Threshold Pedicle Screw | 10-10-80-89 | FDA UDI | Class II | Unknown |
| Duo Ti Expandable Interbody Fusion System | 86-11-28-1 | FDA UDI | Class I | Active |
| Fortress Pedicular Fixation | 10-46-07 | FDA UDI | Class I | Active |
| Medius Midline Retractor System | 66-01-30 | FDA UDI | Class I | Active |
| Elite Expandable Interbody Fusion Device | 10-10-74-39 | FDA UDI | Class II | Active |
| Rampart One Lumbar Interbody Fusion Device | 10-10-76-9 | FDA UDI | Class II | Active |
| Threshold Solid Pedicle Screw | 10-10-80-26 | FDA UDI | Class II | Unknown |
| Rampart One Lumbar Interbody Fusion System | 49-22-01-5 | FDA UDI | Class II | Active |
| Rampart One Lumbar Interbody Fusion Device | 10-10-76-3 | FDA UDI | Class II | Active |
| Rampart-T | 83-01-05-10 | FDA UDI | Class II | Active |
| Threshold V2 Reduction Screw | 10-10-84-16 | FDA UDI | Class II | Active |
| Duo Ti Expandable Interbody Fusion System | 86-12-02-10 | FDA UDI | Class II | Active |
| Navigation | 16-02-01-3 | FDA UDI | Class II | Active |
| Elite Expandable Interbody Fusion Device | 10-10-74-22 | FDA UDI | Class II | Active |
| Rampart-O | 83-02-10-16 | FDA UDI | Class II | Active |
| Elite Expandable Interbody Fusion Device | 10-10-74-7 | FDA UDI | Class II | Active |
| Rampart-O | 83-02-14-15 | FDA UDI | Class II | Active |
| Fortress Pedicular Fixation | 64-10-08 | FDA UDI | Class I | Active |
| Palisade Pedicular Fixation System | 10-10-58-1 | FDA UDI | Class II | Active |
| Threshold Pedicle Screw | 10-10-80-90 | FDA UDI | Class II | Unknown |
| Palisade Pedicular Fixation System | 102-46-01 | FDA UDI | Class I | Active |
| Threshold V2 Pedicular Fixation System | 10-10-83-1 | FDA UDI | Class II | Active |
| Fortress Pedicular Fixation | 64-07-01-2 | FDA UDI | Class I | Active |
| Merlon Retractor System | 19-01-04-06 | FDA UDI | Class I | Active |
| Rampart One Lumbar Interbody Fusion System | 101-51-01-15 | FDA UDI | Class I | Active |
| Capture Facet Screw System | 10-10-45-1 | FDA UDI | U | Active |
| Rampart-O | 10-10-41-11 | FDA UDI | Class II | Active |
| Duo Lumbar Interbody Fusion Device | 10-10-05-25 | FDA UDI | Class II | Active |
| Fortress Pedicle Screw | 10-10-48-36 | FDA UDI | Class II | Unknown |
| Rampart One Lumbar Interbody Fusion System | 49-12-11 | FDA UDI | Class II | Active |
| SOAR Retractor System | 78-03-02-7 | FDA UDI | Class I | Active |
| Rampart-O | 10-10-41-25 | FDA UDI | Class II | Active |
| Palisade Pedicular Fixation System | 67-09-01-0 | FDA UDI | Class I | Active |
| Rampart-O | 83-02-42-10 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Spineology Inc. has one recall record initiated on September 16, 2024. The recall is listed with both open and classified statuses. The reason provided is a potential detachment of the Graft Tube shaft from the Graft Tube funnel head when not used according to the specified surgical instructions.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 16, 2024 | Z-0117-2025 | — | open, classified | Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique. |