Spineology, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
54
Inspections
8
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0117-2025Class IIThe Graft Tube is an optional instrument which, as designed, can be filled with flowable graft materSeptember 16, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemDecember 15, 2025
K251943Spineology Navigation InstrumentsDecember 4, 2025
K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemNovember 1, 2023
K231781OptiMesh Multiplanar Expandable Interbody Fusion SystemOctober 18, 2023
K213876Spineology Navigation InstrumentsAugust 5, 2022
K210155Duo Expandable Interbody Fusion SystemFebruary 19, 2021
DEN200010Spineology Interbody Fusion SystemSeptember 18, 2020
K192047Rampart™ One Lumbar Interbody Fusion SystemAugust 23, 2019
K191091Rampart One Lumbar Interbody Fusion SystemMay 23, 2019
K190055Duo Lumbar Interbody Fusion DeviceMarch 7, 2019
K182322Duo Lumbar Interbody Fusion DeviceOctober 24, 2018
K182345Spineology Navigation InstrumentsSeptember 21, 2018
K181792Duo™ Lumbar Interbody Fusion DeviceAugust 14, 2018
K180796Spineology Navigation InstrumentsMay 2, 2018
K180002Rampart One Lumbar Interbody Fusion DeviceApril 25, 2018
K172518Spineology Navigation InstrumentsJanuary 5, 2018
K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular FAugust 21, 2017
K171660Duo Lumbar Interbody Fusion DeviceAugust 18, 2017
K171724Rampart L Lumbar Interbody Fusion DeviceJuly 24, 2017
K171438Palisade™ Pedicular Fixation SystemJune 2, 2017