OQB
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intervertebral Body Graft Containment Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3085
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OptiMesh Multiplanar Expandable Interbody Fusion System (K251302) | Spineology, Inc. | 2025-12-15 |
| OptiMesh Multiplanar Expandable Interbody Fusion System (K230927) | Spineology, Inc. | 2023-11-01 |
| OptiMesh Multiplanar Expandable Interbody Fusion System (K231781) | Spineology, Inc. | 2023-10-18 |
| Spineology Interbody Fusion System (DEN200010) | Spineology, Inc. | 2020-09-18 |
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Every clearance here is in the API, with alerts when new ones post.