Spineology, Inc.
FDA Regulatory Profile
Spineology, Inc. appears in FDA public data with 1 recall, 54 510(k) clearances, 8 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0117-2025, Class II) was initiated on September 16, 2024. Its most recent 510(k) clearance was granted on December 15, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 54
- Inspections
- 8
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0117-2025 | Class II | The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft mater | September 16, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion System | December 15, 2025 |
| K251943 | Spineology Navigation Instruments | December 4, 2025 |
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion System | November 1, 2023 |
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System | October 18, 2023 |
| K213876 | Spineology Navigation Instruments | August 5, 2022 |
| K210155 | Duo Expandable Interbody Fusion System | February 19, 2021 |
| DEN200010 | Spineology Interbody Fusion System | September 18, 2020 |
| K192047 | Rampart One Lumbar Interbody Fusion System | August 23, 2019 |
| K191091 | Rampart One Lumbar Interbody Fusion System | May 23, 2019 |
| K190055 | Duo Lumbar Interbody Fusion Device | March 7, 2019 |
| K182322 | Duo Lumbar Interbody Fusion Device | October 24, 2018 |
| K182345 | Spineology Navigation Instruments | September 21, 2018 |
| K181792 | Duo Lumbar Interbody Fusion Device | August 14, 2018 |
| K180796 | Spineology Navigation Instruments | May 2, 2018 |
| K180002 | Rampart One Lumbar Interbody Fusion Device | April 25, 2018 |
| K172518 | Spineology Navigation Instruments | January 5, 2018 |
| K172107 | Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular F | August 21, 2017 |
| K171660 | Duo Lumbar Interbody Fusion Device | August 18, 2017 |
| K171724 | Rampart L Lumbar Interbody Fusion Device | July 24, 2017 |
| K171438 | Palisade Pedicular Fixation System | June 2, 2017 |