OQB

Intervertebral Body Graft Containment Device

Product code: OQB
Device name: Intervertebral Body Graft Containment Device
Device class: Class 2
21 CFR: 21 CFR 888.3085
Medical specialty: Orthopedic
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (last 3 years): 4

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-12-15.

Number	Decision date	Applicant	Device name	Summary
K251302	2025-12-15	Spineology, Inc.	OptiMesh Multiplanar Expandable Interbody Fusion Sys	PDF
K230927	2023-11-01	Spineology, Inc.	OptiMesh Multiplanar Expandable Interbody Fusion Sys	PDF
K231781	2023-10-18	Spineology, Inc.	OptiMesh Multiplanar Expandable Interbody Fusion Sys	FDA

2 summaries are archived here for direct download.

Official FDA classification page: OQB

Classification and pathway per current FDA publications. Data from openFDA (CC0).