Intervertebral Body Graft Containment Device
FDA product code OQB · Class II (moderate risk) · 21 CFR 888.3085 · Orthopedic
An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.
3510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional | Spineology, Inc. | 12/15/2025SE |
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional | Spineology, Inc. | 11/01/2023SE |
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Special | Spineology, Inc. | 10/18/2023SE |