FDA Product Code OQB: Intervertebral Body Graft Containment Device
Under FDA product code OQB, intervertebral body graft containment devices are cleared to retain bone graft material within the disc space during spinal fusion.
These mesh or cage structures are placed around bone graft to prevent migration of graft material out of the interbody space while the graft incorporates and fusion occurs. They are used in situations where conventional interbody cages cannot contain loose bone graft adequately.
OQB devices are Class II medical devices, regulated under 21 CFR 888.3085 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Spineology, Inc..
4
Total
3
Cleared
195d
Avg days
2020
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Review times increasing: avg
231d
recently vs 183d historically
FDA 510(k) Cleared Intervertebral Body Graft Containment Device Devices (Product Code OQB)
4 devices
Cleared
Dec 15, 2025
OptiMesh Multiplanar Expandable Interbody Fusion System
Spineology, Inc.
Orthopedic
231d
Cleared
Nov 01, 2023
OptiMesh Multiplanar Expandable Interbody Fusion System
Spineology, Inc.
Orthopedic
212d
Cleared
Oct 18, 2023
OptiMesh Multiplanar Expandable Interbody Fusion System
Spineology, Inc.
Orthopedic
124d
Not Cleared
Sep 18, 2020
Spineology Interbody Fusion System
Spineology, Inc.
Orthopedic
212d
About Product Code OQB - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code OQB since 2020, with 3 receiving FDA clearance (average review time: 195 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA 510(k) Review Time - OQB Product Code
Recent submissions under OQB have taken an average of 231 days to reach a decision - up from 183 days historically. Manufacturers should account for longer review timelines in current project planning.
OQB devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →