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Spineology, Inc.

FDA 510(k) & PMA Approved Devices — 32 products

Total Devices32
Categories5
Latest FDA decision2025-12-15
TypeNumberDevice NameCodeDateActions
510(k) K251302 OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB2025-12-15 View
510(k) K251943 Spineology Navigation InstrumentsOLO2025-12-04 View
510(k) K230927 OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB2023-11-01 View
510(k) K231781 OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB2023-10-18 View
510(k) K213876 Spineology Navigation InstrumentsOLO2022-08-05 View
510(k) K210155 Duo Expandable Interbody Fusion SystemMAX2021-02-19 View
510(k) K192047 Rampart™ One Lumbar Interbody Fusion SystemOVD2019-08-23 View
510(k) K191091 Rampart One Lumbar Interbody Fusion SystemOVD2019-05-23 View
510(k) K190055 Duo Lumbar Interbody Fusion DeviceMAX2019-03-07 View
510(k) K182322 Duo Lumbar Interbody Fusion DeviceMAX2018-10-24 View
510(k) K182345 Spineology Navigation InstrumentsOLO2018-09-21 View
510(k) K181792 Duo™ Lumbar Interbody Fusion DeviceMAX2018-08-14 View
510(k) K180796 Spineology Navigation InstrumentsOLO2018-05-02 View
510(k) K180002 Rampart One Lumbar Interbody Fusion DeviceOVD2018-04-25 View
510(k) K172518 Spineology Navigation InstrumentsOLO2018-01-05 View
510(k) K172107 Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation SystemNKB2017-08-21 View
510(k) K171660 Duo Lumbar Interbody Fusion DeviceMAX2017-08-18 View
510(k) K171724 Rampart L Lumbar Interbody Fusion DeviceMAX2017-07-24 View
510(k) K171438 Palisade™ Pedicular Fixation SystemNKB2017-06-02 View
510(k) K163670 Rampart One Lumbar Interbody Fusion DeviceOVD2017-05-08 View

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