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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) K170268 Fortress™ Pedicular Fixation SystemNKB2017-04-14 View
510(k) K170266 Palisade™ Pedicular Fixation SystemNKB2017-04-14 View
510(k) K170255 Threshold™ V2 Pedicular Fixation SystemNKB2017-04-14 View
510(k) K170251 Threshold™ Pedicular Fixation SystemNKB2017-04-14 View
510(k) K163409 Rampart(TM) T Lumbar Interbody Fusion DeviceMAX2017-03-08 View
510(k) K162879 Elite Expandable Interbody Fusion DeviceMAX2017-01-30 View
510(k) K160074 Rampart D Lumbar Interbody Fusion DeviceMAX2016-10-18 View
510(k) K161694 Threshold™ Pedicular Fixation SystemNKB2016-07-15 View
510(k) K160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion DeviceMAX2016-07-14 View
510(k) K160980 Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemNKB2016-05-26 View
510(k) K153323 Palisade Pedicular Fixation SystemNKB2016-02-23 View
510(k) K153082 Rampart A Lumbar Interbody Fusion DeviceMAX2016-02-04 View

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