Cement, Bone, Vertebroplasty

What Is FDA Product Code NDN?

Cement, Bone, Vertebroplasty is FDA product code NDN, Class 2, 21 CFR 888.3027.

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 2 clearances under this code; the FDA took a median of 171 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 86 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Vendor change control (71), Process control (8) and Storage (3).

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