Spineology, Inc.
Medical device manufacturer in Saint Paul, MN.
53510(k) clearances
0PMA approvals
1recalls
Device types
- MAX Intervertebral Fusion Device With Bone… 22
- NKB Thoracolumbosacral Pedicle Screw System 12
- OLO Orthopedic Stereotaxic Instrument 5
- OVD Intervertebral Fusion Device With… 4
- OQB Intervertebral Body Graft Containment Device 3
- KWQ Appliance, Fixation, Spinal Intervertebral… 2
- EZX Mesh, Surgical, Metal 1
- JDK Prosthesis, Hip, Cement Restrictor 1
- MRW System, Facet Screw Spinal Device 1
- KWP Appliance, Fixation, Spinal Interlaminal 1
- PEK Spinous Process Plate 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional | 12/15/2025SE |
| K251943 | Spineology Navigation InstrumentsOLO · Special | 12/04/2025SE |
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional | 11/01/2023SE |
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Special | 10/18/2023SE |
| K213876 | Spineology Navigation InstrumentsOLO · Traditional | 08/05/2022SE |
| K210155 | Duo Expandable Interbody Fusion SystemMAX · Special | 02/19/2021SE |
| K192047 | Rampart One Lumbar Interbody Fusion SystemOVD · Special | 08/23/2019SE |
| K191091 | Rampart One Lumbar Interbody Fusion SystemOVD · Special | 05/23/2019SE |
| K190055 | Duo Lumbar Interbody Fusion DeviceMAX · Special | 03/07/2019SE |
| K182322 | Duo Lumbar Interbody Fusion DeviceMAX · Traditional | 10/24/2018SE |
| K182345 | Spineology Navigation InstrumentsOLO · Special | 09/21/2018SE |
| K181792 | Duo Lumbar Interbody Fusion DeviceMAX · Special | 08/14/2018SE |
| K180796 | Spineology Navigation InstrumentsOLO · Special | 05/02/2018SE |
| K180002 | Rampart One Lumbar Interbody Fusion DeviceOVD · Traditional | 04/25/2018SE |
| K172518 | Spineology Navigation InstrumentsOLO · Traditional | 01/05/2018SE |
| K172107 | Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress…NKB · Traditional | 08/21/2017SE |
| K171660 | Duo Lumbar Interbody Fusion DeviceMAX · Special | 08/18/2017SE |
| K171724 | Rampart L Lumbar Interbody Fusion DeviceMAX · Special | 07/24/2017SE |
| K171438 | Palisade Pedicular Fixation SystemNKB · Special | 06/02/2017SE |
| K163670 | Rampart One Lumbar Interbody Fusion DeviceOVD · Traditional | 05/08/2017SE |
| K170268 | Fortress Pedicular Fixation SystemNKB · Traditional | 04/14/2017SE |
| K170266 | Palisade Pedicular Fixation SystemNKB · Traditional | 04/14/2017SE |
| K170255 | Threshold V2 Pedicular Fixation SystemNKB · Traditional | 04/14/2017SE |
| K170251 | Threshold Pedicular Fixation SystemNKB · Traditional | 04/14/2017SE |
| K163409 | Rampart(TM) T Lumbar Interbody Fusion DeviceMAX · Traditional | 03/08/2017SE |
| K162879 | Elite Expandable Interbody Fusion DeviceMAX · Traditional | 01/30/2017SE |
| K160074 | Rampart D Lumbar Interbody Fusion DeviceMAX · Traditional | 10/18/2016SE |
| K161694 | Threshold Pedicular Fixation SystemNKB · Special | 07/15/2016SE |
| K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…MAX · Traditional | 07/14/2016SE |
| K160980 | Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemNKB · Special | 05/26/2016SE |
| K153323 | Palisade Pedicular Fixation SystemNKB · Traditional | 02/23/2016SE |
| K153082 | Rampart A Lumbar Interbody Fusion DeviceMAX · Traditional | 02/04/2016SE |
| K152148 | Fortress Pedicular Fixation SystemNKB · Special | 09/02/2015SE |
| K151020 | Rampart-T Interbody Fusion SystemMAX · Special | 07/22/2015SE |
| K143403 | Threshold Pedicular Fixation SystemNKB · Special | 12/18/2014SE |
| K142213 | Via Spinous Process Fixation SystemPEK · Special | 09/10/2014SE |
| K140010 | Fortress Pedicle Screw SystemNKB · Traditional | 04/23/2014SE |
| K133371 | Rampart-LMAX · Special | 01/09/2014SE |
| K132053 | Rampart-O, Rampart-TMAX · Traditional | 09/16/2013SE |
| K131216 | Rampart OMAX · Special | 05/30/2013SE |
| K130396 | Rampart O and Rampart PMAX · Special | 03/25/2013SE |
| K123652 | Spineology PEEK Lumbar Interbody Fusion DeviceMAX · Traditional | 03/22/2013SE |
| K123232 | Spineology Spinous Process PlateKWP · Traditional | 02/07/2013SE |
| K121129 | Spineology PEEK Lumbar Interbody Fusion DeviceMAX · Special | 06/13/2012SE |
| K120293 | Spineology PEEK Lumbar Interbody Fusion DriveMAX · Special | 02/29/2012SE |
| K113030 | Spineology PEEK Bullet Lumbar Interbody Fusion DeviceMAX · Special | 01/26/2012SE |
| K111880 | Spineolgy PEEK Bullet Lumber Interbody Fusion DeviceMAX · Traditional | 09/26/2011SE |
| K110933 | Spineology PEEK Lumbar Interbody Fusion DeviceMAX · Traditional | 06/13/2011SE |
| K092464 | Spineology Facet ScrewMRW · Traditional | 11/09/2009SE |
| K033953 | Optimesh 500E Cement RestrictorJDK · Traditional | 07/06/2004SESU |
| K014200 | OptimeshEZX · Traditional | 11/26/2003SESU |
| K002371 | K-Centrum Anterior Spinal Fixation SystemKWQ · Abbreviated | 09/15/2000SE |
| K990959 | K-Centrum Anterior Spinal Fixation SystemKWQ · Abbreviated | 12/27/1999SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0117-2025 Class II | The Graft Tube is an optional instrument which, as designed, can be filled with flowable…Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as… | 09/16/2024Open, Classified |