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Spineology, Inc.

FDA 510(k) & PMA Approved Devices — 33 products

Total Devices33
Categories5
Latest Approval2025-12-15
TypeNumberDevice NameCodeDate
510(k) K251302 OptiMesh Multiplanar Expandable Interbody Fusion System OQB 2025-12-15 View
510(k) K251943 Spineology Navigation Instruments OLO 2025-12-04 View
510(k) K230927 OptiMesh Multiplanar Expandable Interbody Fusion System OQB 2023-11-01 View
510(k) K231781 OptiMesh Multiplanar Expandable Interbody Fusion System OQB 2023-10-18 View
510(k) K213876 Spineology Navigation Instruments OLO 2022-08-05 View
510(k) K210155 Duo Expandable Interbody Fusion System MAX 2021-02-19 View
510(k) DEN200010 Spineology Interbody Fusion System OQB 2020-09-18 View
510(k) K192047 Rampart™ One Lumbar Interbody Fusion System OVD 2019-08-23 View
510(k) K191091 Rampart One Lumbar Interbody Fusion System OVD 2019-05-23 View
510(k) K190055 Duo Lumbar Interbody Fusion Device MAX 2019-03-07 View
510(k) K182322 Duo Lumbar Interbody Fusion Device MAX 2018-10-24 View
510(k) K182345 Spineology Navigation Instruments OLO 2018-09-21 View
510(k) K181792 Duo™ Lumbar Interbody Fusion Device MAX 2018-08-14 View
510(k) K180796 Spineology Navigation Instruments OLO 2018-05-02 View
510(k) K180002 Rampart One Lumbar Interbody Fusion Device OVD 2018-04-25 View
510(k) K172518 Spineology Navigation Instruments OLO 2018-01-05 View
510(k) K172107 Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System NKB 2017-08-21 View
510(k) K171660 Duo Lumbar Interbody Fusion Device MAX 2017-08-18 View
510(k) K171724 Rampart L Lumbar Interbody Fusion Device MAX 2017-07-24 View
510(k) K171438 Palisade™ Pedicular Fixation System NKB 2017-06-02 View
510(k) K163670 Rampart One Lumbar Interbody Fusion Device OVD 2017-05-08 View
510(k) K170268 Fortress™ Pedicular Fixation System NKB 2017-04-14 View
510(k) K170266 Palisade™ Pedicular Fixation System NKB 2017-04-14 View
510(k) K170255 Threshold™ V2 Pedicular Fixation System NKB 2017-04-14 View
510(k) K170251 Threshold™ Pedicular Fixation System NKB 2017-04-14 View
510(k) K163409 Rampart(TM) T Lumbar Interbody Fusion Device MAX 2017-03-08 View
510(k) K162879 Elite Expandable Interbody Fusion Device MAX 2017-01-30 View
510(k) K160074 Rampart D Lumbar Interbody Fusion Device MAX 2016-10-18 View
510(k) K161694 Threshold™ Pedicular Fixation System NKB 2016-07-15 View
510(k) K160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device MAX 2016-07-14 View
510(k) K160980 Threshold Pedicular Fixation System, Palisade Pedicular Fixation System NKB 2016-05-26 View
510(k) K153323 Palisade Pedicular Fixation System NKB 2016-02-23 View
510(k) K153082 Rampart A Lumbar Interbody Fusion Device MAX 2016-02-04 View
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