FDA product code OQB: Intervertebral Body Graft Containment Device
OQB is the FDA product code for intervertebral body graft containment device. It is a Class II device, regulated under 21 CFR 888.3085 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under OQB, 3 in the last five years. The average 510(k) review took 189 days (median 212); 231 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Intervertebral Body Graft Containment Device |
| Device class | Class II |
| Regulation | 21 CFR 888.3085 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OQB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 2 | 168 |
| 2025 | 1 | 231 |
Compare with all 510(k) review times · Search every OQB clearance
Top OQB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spineology, Inc. | 3 | 2025-12-15 |
Most recent OQB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251302 | Spineology, Inc. | OptiMesh Multiplanar Expandable Interbody Fusion System | 2025-12-15 | 231 |
| K230927 | Spineology, Inc. | OptiMesh Multiplanar Expandable Interbody Fusion System | 2023-11-01 | 212 |
| K231781 | Spineology, Inc. | OptiMesh Multiplanar Expandable Interbody Fusion System | 2023-10-18 | 124 |
Recalls for OQB devices
openFDA lists no recalls for product code OQB.
Frequently asked questions
What is FDA product code OQB?
OQB is the FDA product code for intervertebral body graft containment device. It is a Class II device, regulated under 21 CFR 888.3085 and reviewed by the Orthopedic panel.
What device class is OQB?
Class II, regulation 21 CFR 888.3085. Typical premarket route: 510(k).
How long does a 510(k) take for product code OQB?
Across 3 cleared submissions the average was 189 days from receipt to decision (median 212).
Which companies have the most OQB clearances?
Spineology, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code OQB
- Run a recall and safety report across every OQB manufacturer
- Watch product code OQB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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