FDA 510(k) Applications Submitted by Spineology Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K190055 01/11/2019 Duo Lumbar Interbody Fusion Device Spineology Inc.
K210155 01/21/2021 Duo Expandable Interbody Fusion System Spineology Inc.
K213876 12/13/2021 Spineology Navigation Instruments Spineology Inc.
K111880 07/01/2011 SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE Spineology Inc.
K170251 01/27/2017 ThresholdÖ Pedicular Fixation System SPINEOLOGY INC.
K170255 01/27/2017 ThresholdÖ V2 Pedicular Fixation System SPINEOLOGY INC.
K170266 01/27/2017 PalisadeÖ Pedicular Fixation System Spineology Inc.
K170268 01/27/2017 FortressÖ Pedicular Fixation System Spineology Inc.
K172518 08/21/2017 Spineology Navigation Instruments Spineology Inc.
K160906 04/01/2016 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device SPINEOLOGY INC.
K180002 01/02/2018 Rampart One Lumbar Interbody Fusion Device Spineology Inc.
K180796 03/27/2018 Spineology Navigation Instruments Spineology Inc.
K171438 05/16/2017 PalisadeÖ Pedicular Fixation System Spineology Inc.
K171660 06/05/2017 Duo Lumbar Interbody Fusion Device Spineology Inc.
K171724 06/12/2017 Rampart L Lumbar Interbody Fusion Device Spineology Inc.
K161694 06/20/2016 ThresholdÖ Pedicular Fixation System Spineology Inc.
K172107 07/12/2017 ThresholdÖ V2 Pedicular Fixation System, ThresholdÖ Pedicular Fixation System, FortressÖ Pedicular Fixation System, PalisadeÖ Pedicular Fixation System Spineology Inc.
K162879 10/14/2016 Elite Expandable Interbody Fusion Device Spineology Inc.
K163409 12/05/2016 Rampart(TM) T Lumbar Interbody Fusion Device Spineology Inc.
K163670 12/27/2016 Rampart One Lumbar Interbody Fusion Device SPINEOLOGY INC.
K160074 01/14/2016 Rampart D Lumbar Interbody Fusion Device Spineology Inc.
K181792 07/05/2018 DuoÖ Lumbar Interbody Fusion Device Spineology Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact