Product code OQB

Device name

Intervertebral Body Graft Containment Device

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3085

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset