Plate, Cranioplasty, Preformed, Non-Alterable

What Is FDA Product Code GXN?

Plate, Cranioplasty, Preformed, Non-Alterable is FDA product code GXN, Class 2, 21 CFR 882.5330.

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 1 clearance under this code; the FDA took 303 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 11 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Process control (6), Device Design (4) and Labeling False and Misleading (1).

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