OQB — Intervertebral Body Graft Containment Device Class II

FDA Device Classification

Classification Details

Product Code
OQB
Device Class
Class II
Regulation Number
888.3085
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251302spineologyOptiMesh Multiplanar Expandable Interbody Fusion SystemDecember 15, 2025
K230927spineologyOptiMesh Multiplanar Expandable Interbody Fusion SystemNovember 1, 2023
K231781spineologyOptiMesh Multiplanar Expandable Interbody Fusion SystemOctober 18, 2023
DEN200010spineologySpineology Interbody Fusion SystemSeptember 18, 2020