Software for Diagnosis/Treatment

What Is It?

Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions

How Is OSN Classified?

Software For Diagnosis/Treatment is FDA product code OSN, Class 2, 21 CFR 888.3030.

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. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2017. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.