Orthosis, Spondylolisthesis Spinal Fixation

What Is FDA Product Code MNH?

Orthosis, Spondylolisthesis Spinal Fixation is FDA product code MNH, Class 2, 21 CFR 888.3070.

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 8 clearances under this code; the FDA took a median of 163 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 15 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (5), Device Design (3) and Employee error (2).

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