Appliance, Fixation, Spinal Intervertebral Body

What Is FDA Product Code KWQ?

Appliance, Fixation, Spinal Intervertebral Body is FDA product code KWQ, Class 2, 21 CFR 888.3060.

How Does It Reach the US Market?

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 4 clearances under this code; the FDA took a median of 172 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 214 recalls under this product code since 2002. None was by a company in China. The root causes the FDA records most often are Device Design (77), Nonconforming Material/Component (9) and Error in labeling (8).

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