Spineology, Inc.
Saint Paul, MN, US
SPINEOLOGY INC. appears in FDA device records in Saint Paul, MN. FDA records list 54 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Spineology, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- The Spineology Grouprecall
510(k) clearance history
Showing 50 of 54FDA records hold 54 510(k) clearances for Spineology, Inc. between 1999 and 2025. The busiest year on record is 2017, with 11. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2009 | 1 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 5 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 6 |
| 2017 | 11 |
| 2018 | 6 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion System | OQB | Substantially Equivalent | |
| K251943 | Spineology Navigation Instruments | OLO | Substantially Equivalent | |
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion System | OQB | Substantially Equivalent | |
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System | OQB | Substantially Equivalent | |
| K213876 | Spineology Navigation Instruments | OLO | Substantially Equivalent | |
| K210155 | Duo Expandable Interbody Fusion System | MAX | Substantially Equivalent | |
| DEN200010 | Spineology Interbody Fusion System | OQB | Unknown | |
| K192047 | Rampart™ One Lumbar Interbody Fusion System | OVD | Substantially Equivalent | |
| K191091 | Rampart One Lumbar Interbody Fusion System | OVD | Substantially Equivalent | |
| K190055 | Duo Lumbar Interbody Fusion Device | MAX | Substantially Equivalent | |
| K182322 | Duo Lumbar Interbody Fusion Device | MAX | Substantially Equivalent | |
| K182345 | Spineology Navigation Instruments | OLO | Substantially Equivalent | |
| K181792 | Duo™ Lumbar Interbody Fusion Device | MAX | Substantially Equivalent | |
| K180796 | Spineology Navigation Instruments | OLO | Substantially Equivalent | |
| K180002 | Rampart One Lumbar Interbody Fusion Device | OVD | Substantially Equivalent | |
| K172518 | Spineology Navigation Instruments | OLO | Substantially Equivalent | |
| K172107 | Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System | NKB | Substantially Equivalent | |
| K171660 | Duo Lumbar Interbody Fusion Device | MAX | Substantially Equivalent | |
| K171724 | Rampart L Lumbar Interbody Fusion Device | MAX | Substantially Equivalent | |
| K171438 | Palisade™ Pedicular Fixation System | NKB | Substantially Equivalent | |
| K163670 | Rampart One Lumbar Interbody Fusion Device | OVD | Substantially Equivalent | |
| K170268 | Fortress™ Pedicular Fixation System | NKB | Substantially Equivalent | |
| K170266 | Palisade™ Pedicular Fixation System | NKB | Substantially Equivalent | |
| K170255 | Threshold™ V2 Pedicular Fixation System | NKB | Substantially Equivalent | |
| K170251 | Threshold™ Pedicular Fixation System | NKB | Substantially Equivalent | |
| K163409 | Rampart(TM) T Lumbar Interbody Fusion Device | MAX | Substantially Equivalent | |
| K162879 | Elite Expandable Interbody Fusion Device | MAX | Substantially Equivalent | |
| K160074 | Rampart D Lumbar Interbody Fusion Device | MAX | Substantially Equivalent | |
| K161694 | Threshold™ Pedicular Fixation System | NKB | Substantially Equivalent | |
| K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device | MAX | Substantially Equivalent | |
| K160980 | Threshold Pedicular Fixation System, Palisade Pedicular Fixation System | NKB | Substantially Equivalent | |
| K153323 | Palisade Pedicular Fixation System | NKB | Substantially Equivalent | |
| K153082 | Rampart A Lumbar Interbody Fusion Device | MAX | Substantially Equivalent | |
| K152148 | Fortress Pedicular Fixation System | NKB | Substantially Equivalent | |
| K151020 | Rampart-T Interbody Fusion System | MAX | Substantially Equivalent | |
| K143403 | Threshold Pedicular Fixation System | NKB | Substantially Equivalent | |
| K142213 | VIA SPINOUS PROCESS FIXATION SYSTEM | PEK | Substantially Equivalent | |
| K140010 | FORTRESS PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K133371 | RAMPART-L | MAX | Substantially Equivalent | |
| K132053 | RAMPART-O, RAMPART-T | MAX | Substantially Equivalent | |
| K131216 | RAMPART O | MAX | Substantially Equivalent | |
| K130396 | RAMPART O AND RAMPART P | MAX | Substantially Equivalent | |
| K123652 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K123232 | SPINEOLOGY SPINOUS PROCESS PLATE | KWP | Substantially Equivalent | |
| K121129 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K120293 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE | MAX | Substantially Equivalent | |
| K113030 | SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K111880 | SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K110933 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K092464 | SPINEOLOGY FACET SCREW | MRW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2135156 | 3003179719 | SPINEOLOGY INC. | 7800 THIRD STREET N., Saint Paul, MN 55128 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- GBACatheter, Balloon Type
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- OQBIntervertebral Body Graft Containment Device
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- KDDKit, Surgical Instrument, Disposable
- EZXMesh, Surgical, Metal
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- JDKProsthesis, Hip, Cement Restrictor
- GADRetractor
- PEKSpinous Process Plate
- MRWSystem, Facet Screw Spinal Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0117-2025 | 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 deployment of the graft material out of the Graft Tube and adjacent to where the implant is to be placed, as supported within the Surgical Technique Guide. | Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique. | Class II | Open, Classified | |
| Z-0679-05 | Platen, Catalog # 301-124, is a mechanism used to lock or hold the fill tube in place as it is filled with graft material. Platen is identified with Spineology, catalog number and lot number printed directly onto the metal. | Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. Fill tubes are used in delivery of bone graft materials. | Terminated | ||
| Z-0678-05 | Fill Tube,straight, Catalog # 300-1001, is used for the delivery of granular autograft or allograft into Spineology''s OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto the metal. | Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. Fill tubes are used in delivery of bone graft materials. | Terminated | ||
| Z-0677-05 | Fill Tube,diverted, Catalog # 300-1002, is used for the delivery of granular autograft or allograft into Spineology''s OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto the metal. | Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. Fill tubes are used in delivery of bone graft materials. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain