Orthosis, Spinal Pedicle Fixation

How Is MNI Classified?

Orthosis, Spinal Pedicle Fixation is FDA product code MNI, Class 2, 21 CFR 888.3070.

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 7 clearances under this code; the FDA took a median of 128 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 213 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Device Design (175), Labeling design (8) and Process control (5).

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