Staple Driver

Which Manufacturers in China Make This?

One manufacturer in China holds an FDA registration for this device type, based in Shanghai.

Arthrex (Shanghai) Co., Ltd. Shanghai

How Is HXJ Classified?

Staple Driver is FDA product code HXJ, Class 1, 21 CFR 888.4540.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2006. 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.

Staple Driver

Extension ROD Staple Driver-Extractor

Staple Driver

Impactor Assembly

Catalogue number 202-1137, listed by Xiros Ltd, United Kingdom, under Staple Driver. 1 manufacturer in China is registered for this product code.

Staple Driver

Large UNI-Clip®

The straight drilling guide, positionned with the osteotomy centered between the two sleeves, is used to guide the drills while drilling the holes for the straight staples.

Staple Driver