Product code OVD

Device name

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3080

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Source

FDA openFDA device classification dataset