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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)
3
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
4 (all years; only the last 3 years are listed here)

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.

NumberDecision dateApplicantDevice nameSummary
K2513022025-12-15Spineology, Inc.OptiMesh Multiplanar Expandable Interbody Fusion Sys…PDF
K2309272023-11-01Spineology, Inc.OptiMesh Multiplanar Expandable Interbody Fusion Sys…PDF
K2317812023-10-18Spineology, 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).