Intervertebral Fusion Device With Integrated Fixation, Cervical

What Is This Device?

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

How Is OVE Classified?

Intervertebral Fusion Device With Integrated Fixation, Cervical is FDA product code OVE, Class 2, 21 CFR 888.3080.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 214 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 12 recalls under this product code since 2013. None was by a company in China. The root causes the FDA records most often are Process control (4), Nonconforming Material/Component (2) and Employee error (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.