Applier, Staple, Surgical,

Who Makes This Device Type in China?

3 manufacturers in China hold an FDA registration for this device type, concentrated in Hong Kong, Jiangsu and Shandong.

Changzhou 3R Medical Device Technology Co., Ltd. Jiangsu
Svenson Network Holdings Limited Hong Kong
Xinhua Surgical Instrument Co., Ltd. Shandong

What Is FDA Product Code GEF?

Applier, Staple, Surgical, is FDA product code GEF, Class 1, 21 CFR 878.4800.

How Does It Reach the US Market?

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.

Applier, Staple, Surgical,

Intrafix

INTRAFIX Tibial Sheath Inserter with Fixed Handle

Applier, Staple, Surgical,

Tacit

TACIT Inserter 2.0mm

Applier, Staple, Surgical,

Meniscal Deployment Gun with Malleable Graft Retractor

Applier, Staple, Surgical,

Catalogue number 1100-01, listed by Zimmer, Inc., United States, under Applier, Staple, Surgical,. 3 manufacturers in China are registered for this product code.

Applier, Staple, Surgical,