Company · US
Spineology, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2025. Name variants (Inc, Corp, punctuation) are merged.
54510(k) clearances (2 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 22 |
| NKB | Thoracolumbosacral Pedicle Screw System | 12 |
| OLO | Orthopedic Stereotaxic Instrument | 5 |
| OQB | Intervertebral Body Graft Containment Device | 4 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 |
| EZX | Mesh, Surgical, Metal | 1 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
| PEK | Spinous Process Plate | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2025 | K251302 | OptiMesh Multiplanar Expandable Interbody Fusion System Spineology, Inc. | OQB |
| Dec 4, 2025 | K251943 | Spineology Navigation Instruments Spineology, Inc. | OLO |
| Nov 1, 2023 | K230927 | OptiMesh Multiplanar Expandable Interbody Fusion System Spineology, Inc. | OQB |
| Oct 18, 2023 | K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System Spineology, Inc. | OQB |
| Aug 5, 2022 | K213876 | Spineology Navigation Instruments Spineology, Inc. | OLO |
| Feb 19, 2021 | K210155 | Duo Expandable Interbody Fusion System Spineology, Inc. | MAX |
| Sep 18, 2020 | DEN200010 | Spineology Interbody Fusion System Spineology, Inc. | OQB |
| Aug 23, 2019 | K192047 | Rampart One Lumbar Interbody Fusion System Spineology, Inc. | OVD |
| May 23, 2019 | K191091 | Rampart One Lumbar Interbody Fusion System Spineology, Inc. | OVD |
| Mar 7, 2019 | K190055 | Duo Lumbar Interbody Fusion Device Spineology, Inc. | MAX |
| Oct 24, 2018 | K182322 | Duo Lumbar Interbody Fusion Device Spineology, Inc. | MAX |
| Sep 21, 2018 | K182345 | Spineology Navigation Instruments Spineology, Inc. | OLO |
| Aug 14, 2018 | K181792 | Duo Lumbar Interbody Fusion Device Spineology, Inc. | MAX |
| May 2, 2018 | K180796 | Spineology Navigation Instruments Spineology, Inc. | OLO |
| Apr 25, 2018 | K180002 | Rampart One Lumbar Interbody Fusion Device Spineology, Inc. | OVD |
| Jan 5, 2018 | K172518 | Spineology Navigation Instruments Spineology, Inc. | OLO |
| Aug 21, 2017 | K172107 | Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular Fixation System, Pali Spineology, Inc. | NKB |
| Aug 18, 2017 | K171660 | Duo Lumbar Interbody Fusion Device Spineology, Inc. | MAX |
| Jul 24, 2017 | K171724 | Rampart L Lumbar Interbody Fusion Device Spineology, Inc. | MAX |
| Jun 2, 2017 | K171438 | Palisade Pedicular Fixation System Spineology, Inc. | NKB |
| May 8, 2017 | K163670 | Rampart One Lumbar Interbody Fusion Device Spineology, Inc. | OVD |
| Apr 14, 2017 | K170268 | Fortress Pedicular Fixation System Spineology, Inc. | NKB |
| Apr 14, 2017 | K170266 | Palisade Pedicular Fixation System Spineology, Inc. | NKB |
| Apr 14, 2017 | K170255 | Threshold V2 Pedicular Fixation System Spineology, Inc. | NKB |
| Apr 14, 2017 | K170251 | Threshold Pedicular Fixation System Spineology, Inc. | NKB |
| Mar 8, 2017 | K163409 | Rampart(TM) T Lumbar Interbody Fusion Device Spineology, Inc. | MAX |
| Jan 30, 2017 | K162879 | Elite Expandable Interbody Fusion Device Spineology, Inc. | MAX |
| Oct 18, 2016 | K160074 | Rampart D Lumbar Interbody Fusion Device Spineology, Inc. | MAX |
| Jul 15, 2016 | K161694 | Threshold Pedicular Fixation System Spineology, Inc. | NKB |
| Jul 14, 2016 | K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion De Spineology, Inc. | MAX |
| May 26, 2016 | K160980 | Threshold Pedicular Fixation System, Palisade Pedicular Fixation System Spineology, Inc. | NKB |
| Feb 23, 2016 | K153323 | Palisade Pedicular Fixation System Spineology, Inc. | NKB |
| Feb 4, 2016 | K153082 | Rampart A Lumbar Interbody Fusion Device Spineology, Inc. | MAX |
| Sep 2, 2015 | K152148 | Fortress Pedicular Fixation System Spineology, Inc. | NKB |
| Jul 22, 2015 | K151020 | Rampart-T Interbody Fusion System Spineology, Inc. | MAX |
| Dec 18, 2014 | K143403 | Threshold Pedicular Fixation System Spineology, Inc. | NKB |
| Sep 10, 2014 | K142213 | VIA SPINOUS PROCESS FIXATION SYSTEM Spineology, Inc. | PEK |
| Apr 23, 2014 | K140010 | FORTRESS PEDICLE SCREW SYSTEM Spineology, Inc. | NKB |
| Jan 9, 2014 | K133371 | RAMPART-L Spineology, Inc. | MAX |
| Sep 16, 2013 | K132053 | RAMPART-O, RAMPART-T Spineology, Inc. | MAX |
| May 30, 2013 | K131216 | RAMPART O Spineology, Inc. | MAX |
| Mar 25, 2013 | K130396 | RAMPART O AND RAMPART P Spineology, Inc. | MAX |
| Mar 22, 2013 | K123652 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE Spineology, Inc. | MAX |
| Feb 7, 2013 | K123232 | SPINEOLOGY SPINOUS PROCESS PLATE Spineology, Inc. | KWP |
| Jun 13, 2012 | K121129 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE Spineology, Inc. | MAX |
| Feb 29, 2012 | K120293 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE Spineology, Inc. | MAX |
| Jan 26, 2012 | K113030 | SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE Spineology, Inc. | MAX |
| Sep 26, 2011 | K111880 | SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE Spineology, Inc. | MAX |
| Jun 13, 2011 | K110933 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE Spineology, Inc. | MAX |
| Nov 9, 2009 | K092464 | SPINEOLOGY FACET SCREW Spineology, Inc. | MRW |
Newest 50 of 54.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2024 | Spineology, Inc. The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deplo Open, Classified |
LXH | None listed |