Applier, Cerclage

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Shanghai, Jiangsu and Shandong: 5 hold an FDA registration. 1 is a contract manufacturer.

B.Braun Medical (Suzhou) Co,.Ltd Jiangsu, contract manufacturer
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

How Is HXN Classified?

Applier, Cerclage is FDA product code HXN, Class 1, 21 CFR 888.4540.

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, Cerclage

Cable-Ready®

Catalogue number 2232-08-01, listed by Zimmer, Inc., United States, under Applier, Cerclage. 5 manufacturers in China are registered for this product code.

Applier, Cerclage

Ligapass

Ligapass Tension Pulley Handle

Applier, Cerclage

Aesculap

DEMEL Wire Guide, curved, 11 1/4", (285 mm), blunt, medium, non-sterile, reusable

Applier, Cerclage

BMP Cable System

Catalogue number 350808, listed by Biomet Orthopedics, United States, under Applier, Cerclage. 5 manufacturers in China are registered for this product code.

Applier, Cerclage