Intervertebral Fusion Device With Bone Graft, Cervical

What Is It?

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

How Is ODP Classified?

Intervertebral Fusion Device With Bone Graft, Cervical is FDA product code ODP, 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 193 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 11 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Labeling False and Misleading (3), Device Design (2) and Error in labeling (1).

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