Spineology, Inc. - FDA 510(k) Cleared Devices
Recent clearances: OptiMesh Multiplanar Expandable Interbody Fusion System, Spineology Navigation Instruments, OptiMesh Multiplanar Expandable Interbody Fusion System
54
Total
51
Cleared
1
Denied
FDA 510(k) Regulatory Record - Spineology, Inc. Orthopedic ✕
53 devices
Cleared
Dec 15, 2025
OptiMesh Multiplanar Expandable Interbody Fusion System
Orthopedic
231d
Cleared
Dec 04, 2025
Spineology Navigation Instruments
Orthopedic
163d
Cleared
Nov 01, 2023
OptiMesh Multiplanar Expandable Interbody Fusion System
Orthopedic
212d
Cleared
Oct 18, 2023
OptiMesh Multiplanar Expandable Interbody Fusion System
Orthopedic
124d
Cleared
Aug 05, 2022
Spineology Navigation Instruments
Orthopedic
235d
Cleared
Feb 19, 2021
Duo Expandable Interbody Fusion System
Orthopedic
29d
Not Cleared
Sep 18, 2020
Spineology Interbody Fusion System
Orthopedic
212d
Cleared
Aug 23, 2019
Rampart™ One Lumbar Interbody Fusion System
Orthopedic
23d
Cleared
May 23, 2019
Rampart One Lumbar Interbody Fusion System
Orthopedic
29d
Cleared
Mar 07, 2019
Duo Lumbar Interbody Fusion Device
Orthopedic
55d
Cleared
Oct 24, 2018
Duo Lumbar Interbody Fusion Device
Orthopedic
58d
Cleared
Sep 21, 2018
Spineology Navigation Instruments
Orthopedic
24d
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