Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

How Is KTT Classified?

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component is FDA product code KTT, Class 2, 21 CFR 888.3030.

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 312 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 89 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 (26), Packaging (10) and Process control (9).

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